(386 days)
Permanent D-Aneurysm-Clips are intended for permanent occlusion of cerebral aneurysms. Temporary D-Aneurysm-Clips are intended for temporary occlusion of intracranial blood vessels and cerebral aneurysms.
The D-Aneurysm Clip Appliers are intended to be used for holding and applying D-Aneurysm-Clips. The D-Aneurysm Clip Appliers are not compatible with other systems.
D-Aneurysm-Clips are available in two principle sizes (Standard and Mini) and several forms of jaws (straight, curved, angled, bayonet, fenestrated, non-fenestrated). Both sizes are available for permanent or temporary occlusion.
D-Aneurysm Clip Appliers are designed to be used with both principle sizes of D-Aneurysm-Clips, Standard and Mini.
The D-Clip is manufactured out of three parts, two of those forming the body and one the spring. With D-Clip Appliers it is grasped from the outside to open, close and guide the clip.
The D-Clip Appliers exists in two versions: a version with double action handles and one version with memory effect. Both versions are applied the same way. Pressing the handle will open the jaw.
This document describes the performance testing for the Peter Lazic GmbH D-Aneurysm-Clips and D-Aneurysm Clip Appliers, demonstrating their substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| D-Aneurysm-Clips | ||
| Microbiological performance qualification of gamma radiation sterilization | Sterility assurance level (SAL) < 10^-6, with effective inactivation of microbial contamination. | Average bioburden of 2.0 cfu/sample. Microbial contamination inactivated by 5.40 kGy ± 3.7% irradiation. SAL < 10^-6 achieved with a minimum dose of 25 kGy. |
| Validation of the sterile barrier system (SBS) | Requirements for microbial barrier properties met. Shelf life confirmed after 5 years accelerated aging. | Requirements for microbial barrier properties met. Shelf life confirmed after 5 years accelerated aging. |
| MRI Safety | No additional hazard or risk to a patient undergoing MRI in specified static magnetic field (1.5 and 3-Tesla) and spatial gradient magnetic field (4,000-Gauss/cm). Maximum temperature rise of < 1.8°C. | MR Conditional. No additional hazard or risk with 1.5 and 3-Tesla static magnetic fields and 4,000-Gauss/cm spatial gradient. Max temperature rise of 1.7°C (D-Clip) and 1.8°C (L-Clip) after 15 min scanning. D-Clip artifact size: 10mm; L-Clip artifact size: 15mm. |
| LAL endotoxin test | Endotoxins not detected. | Endotoxins not detected. |
| Degradation of closing force tests | Reduction of closing force < 5% of nominal closing force after 10 maximum openings. | D-Clips, L-Clips, and Yasargil Clips fulfilled ISO 9713 requirements. Closing forces are deemed equivalent. |
| D-Aneurysm Clip Appliers | ||
| Microbiological efficiency control of automated cleaning and disinfection method | Reduction of Bacillus atrophaeus by at least 5.2 log steps. Reduction of Mycobacterium terrae by at least 6.8 log steps. | Bacillus atrophaeus reduced by at least 5.2 log steps. Mycobacterium terrae reduced by at least 6.8 log steps. |
| Microbiological efficiency control of manual cleaning and disinfection method | No visible remains of contamination. Reduction of Bacillus atrophaeus by at least 4.8 log steps. Reduction of Mycobacterium terrae by at least 5.3 log steps. | No visible remains of contamination. Bacillus atrophaeus reduced by at least 4.8 log steps. Mycobacterium terrae reduced by at least 5.3 log steps. |
| Microbiological efficiency control of steam sterilization | Sterilization with sufficient spore log reduction (>12) using standard parameters (121°C, 20 min, and 134°C, 4min). | All tested devices free of microbial growth in three independent half-cycle qualification runs. Sufficient spore log reduction (>12) demonstrated. |
| Bending test (Memory material in straight condition) | Material can be bent without much effort. Material properties not changed after repeated bending. | Approximately 40 N required to deform the shaft. Force required to bend the shaft was similar after 100 bends, indicating no change in material properties. |
| Defining the bending cycles to possible function restrictions | No functional limitations after repeated bending and straightening cycles. | All 10 tested appliers remained fully functional after 30 repetitions (15 times 90° bending, 15 times straightening). |
| Behavior of the D-Clip Applying forceps after repeated use and reprocessing | Full function maintained after maximum simulated use and reprocessing cycles. | All 10 tested Memory D-Aneurysm-Clip Appliers showed full function after 100 cycles of bending, cleaning, and sterilization. |
2. Sample Sizes Used for the Test Set and Data Provenance
- D-Aneurysm-Clips:
- Microbiological performance qualification: 10 samples of worst-case clips.
- Degradation of closing force tests: Not explicitly stated, but the test mentions "The tested D-Clips did fulfill..." and "The test results of the L-Clips and the Yasargil Clips fulfilled..." implying multiple samples for each.
- D-Aneurysm Clip Appliers:
- Microbiological efficiency (automated/manual cleaning & disinfection): Three contaminated reference products for each method.
- Microbiological efficiency (steam sterilization): Three qualification runs with three inoculated test samples each.
- Defining the bending cycles to possible function restrictions: 10 applying forceps.
- Behavior after repeated use and reprocessing: 10 D-Clip appliers.
The data provenance is retrospective as the studies were conducted to support the 510(k) submission, referencing existing standards and predicate device data. The country of origin of the data is Germany, as the applicant is Peter Lazic GmbH in Tuttlingen, Germany.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This submission does not involve a clinical study with human subject data requiring expert consensus for ground truth. The tests conducted are benchtop and laboratory performance tests, comparing the new device against established standards (e.g., ISO 9713, ISO 5832) and predicate device specifications. Therefore, the concept of "experts establishing ground truth for the test set" in a clinical sense does not apply here. The "ground truth" for these engineering and sterility tests is derived from adherence to recognized testing standards and validated methodologies.
4. Adjudication Method for the Test Set
Not applicable, as this is not a study involving human readers or clinical data that would require an adjudication method. The results are from physical and microbiological tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This submission is for a physical medical device (aneurysm clips and appliers), not an AI-powered diagnostic or assistive tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This submission is for a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for these tests is based on:
- International Standards: Adherence to standards like ISO 9713 (for closing force), ISO 5832 (for materials), and methods for sterility and cleaning validation.
- Predicate Device Performance: Direct comparison of the D-Aneurysm-Clips and D-Aneurysm Clip Appliers against the performance characteristics of the legally marketed predicate devices (L-Clip, Yasargil Aneurysm Clip, and their appliers), which have established safety and effectiveness.
- Validated Test Methodologies: Scientific and engineering principles applied in laboratory settings to determine physical properties, material compatibility, and biological safety.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning study, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set as this is not an AI/machine learning study.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 12, 2019
Peter Lazic GmbH Sven Lazic Executive Vice President Immelmannweg 2 78532 Tuttlingen, Germany
Re: K180757
Device Name: D-Aneurysm-Clips; D-Aneurysm Clip Appliers Regulation Number: 21 CFR 882.5200 Regulation Name: Aneurysm Clip Regulatory Class: Class II Product Code: HCH, HCI Dated: March 12, 2019 Received: March 15, 2019
Dear Sven Lazic:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database t identifies combination product submissions. The general controls of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov
1 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm
{1}------------------------------------------------
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or post-marketing safety reporting (21 CFR 4, Subpart B) for combination products'; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advices and CDRH Learn . Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2 https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm
3 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/
4 http://www.fda.gov/Training/CDRHLearn
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image is a logo for Peter Lazic Microsurgical Innovations. The logo features a stylized letter "P" in gray, with a circular cutout in the upper right portion of the letter. To the right of the "P" is the name "PETER" stacked above "MICROSURGICAL INNOVATIONS" in gray. To the right of "PETER" is the name "LAZIC" in yellow.
| DATE OF APPLICATION: | 04/09/2019 |
|---|---|
| APPLICANT: | Peter Lazic GmbH |
| Immelmannweg 2 | |
| D-78532 Tuttlingen | |
| Germany | |
| Tel: + 49 (7461) 966430 | |
| Fax: +49 (7461) 8745 | |
| E-Mail: info@lazic.de | |
| CONTACT PERSON: | Sven Lazic |
Sver Executive Vice President Tel.: +49 (0)7461-96643-20 E-Mail: s.lazic@lazic.de
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for Peter Lazic Microsurgical Innovations. The logo features a stylized letter "P" in gray, with a cutout circle in the upper right portion of the letter. Below the "P" is the name "PETER LAZIC" with "PETER" in gray and "LAZIC" in yellow. Underneath the name is the text "MICROSURGICAL INNOVATIONS" in a smaller, gray font.
1 Device Name
| Trade Name of legally marketed devices: | L-ClipYasargil Aneurysm ClipL-Clip AppliersYasargil Aneurysm Clip Appliers |
|---|---|
| Trade Name of modified device: | D-Aneurysm-ClipsD-Aneurysm Clip Appliers |
| Common Name: | Aneurysm ClipAneurysm Clip Appliers |
| Device Classification Name: | Aneurysm ClipAneurysm Clip Appliers |
Classification 2
Our aneurysm clips and aneurysm clip appliers are classified as follows:
| Device: | D-Aneurysm-Clips | D-Aneurysm Clip Appliers |
|---|---|---|
| Devicedescription: | Aneurysm clip | Aneurysm clip applier |
| MedicalSpecialty: | Neurology | Neurology |
| Product Code: | HCH | HCI |
| RegulationNumber: | 882.5200 | 882.4175 |
| Device Class: | 2 | 2 |
Substantial Equivalence 3
The Lazic D-Aneurysm-Clip is substantial equivalent to the already cleared device of Lazic; the L-Clip and the Yasargil Aneurysm Clip.
The Lazic D-Aneurysm Clip Applier is substantial equivalent to the already cleared device of Lazic; the L-Clip Appliers and the Yasargil Aneurysm Clip Appliers.
Description of the Device 4
D-Aneurysm-Clips are available in two principle sizes (Standard and Mini) and several forms of jaws (straight, curved, angled, bayonet, fenestrated, non-fenestrated). Both sizes are available for permanent or temporary occlusion.
D-Aneurysm Clip Appliers are designed to be used with both principle sizes of D-Aneurysm-Clips, Standard and Mini.
{4}------------------------------------------------
Image /page/4/Picture/1 description: The image is a logo for Peter Lazic Microsurgical Innovations. The logo features a large, gray letter "P" with a cutout in the upper right corner. Below the "P" is the name "PETER" in gray, followed by "LAZIC" in a yellow box. Underneath the name is the text "MICROSURGICAL INNOVATIONS" in a smaller font.
4.1 Intended Use/Indications for Use
4.1.1 D-Aneurysm-Clips
Permanent D-Aneurysm-Clips are intended for permanent occlusion of cerebral aneurysms. Temporary D-Aneurysm-Clips are intended for temporary occlusion of intracranial blood vessels and cerebral aneurysms.
4.1.2 D-Aneurysm Clip Appliers
The D-Aneurysm Clip Appliers are intended to be used for holding and applying D-Aneurysm-Clips. The D-Aneurysm Clip Appliers are not compatible with other systems.
4.2 Design
4.2.1 D-Aneurysm-Clip
The D-Clip is manufactured out of three parts, two of those forming the body and one the spring. With D-Clip Appliers it is grasped from the outside to open, close and guide the clip.
4.2.2D-Aneurysm Clip Appliers
The D-Clip Appliers exists in two versions: a version with double action handles and one version with memory effect. Both versions are applied the same way. Pressing the handle will open the jaw.
4.3 Material
The D-Clip is made of Titanium according to ISO 5832-2 and Titanium alloy Ti6Al4V according to ISO 5832-3.
4.4 Usage/ Application
4.4.1 D-Aneurysm-Clip
Both, the permanent and temporary D-Clips are intended for use by trained surgeons thoroughly familiar with the surgical technique and use of these medical devices.
4.4.2 D-Aneurysm Clip Appliers
The D-Clip Applying Forceps serve for opening and closing the D-Clips. Using the forceps, the aneurysm clip is applied, repositioned or removed in the target tissue. The clip applying forceps have no function of their own and may only be used in combination with the suited D-Clips.
{5}------------------------------------------------
Image /page/5/Picture/1 description: The image shows the logo for Peter Lazic Microsurgical Innovations. The logo features a gray letter "P" with the words "PETER LAZIC" in black text below it. To the right of "PETER" is a yellow rectangle that highlights the word "LAZIC". Below the name is the phrase "MICROSURGICAL INNOVATIONS" in a smaller, gray font.
4.5 Technological characteristics
| Device | Primary Predicate Device | 510(k) Number | 510(k) Holder |
|---|---|---|---|
| D-Aneurysm-Clips | L-ClipYasargil Aneurysm Clip | K081489 | Peter Lazic GmbH |
| D-Aneurysm Clip Appliers | L-Clip AppliersYasargil Aneurysm Clip Appliers | K081489 | Peter Lazic GmbH |
4.5.1 Technological characteristics of D-Aneurysm-Clip
| Technological characteristics | K081489 | Change discussion | |
|---|---|---|---|
| Peter Lazic GmbH | Peter Lazic GmbH | ||
| D-Aneurysm-Clips | Lazic L-Clips / Yasargil Aneurysm Clips | ||
| Design | D-clip: Outer application by theapplying forcepsImage: D-clip | L-clip: Inner application by the applying forcepsImage: L-clipYasargil: Outer application by the applyingforcepsImage: Yasargil clip | Compared to the L-clipthe only difference is thatthe D-clip is applied fromthe outside. All otherdesign features areidentical. For bothdevices the same springis used. Meaning theyeven share a semi-finished good.Compared to the Yasargilclip the D-clip has asimilar outer application,but different springdesign.SubstantiallyEquivalent |
| --- | K081489 | Change discussion | |
| Technological characteristics | Peter Lazic GmbH | Peter Lazic GmbH | |
| Lazic D-Aneurysm-Clips | Lazic L-Clips / Yasargil Aneurysm Clips | ||
| Closing Force | Mini perm.: 110-130 gmsMini temp.: 70-90 gmsStandard perm.: 150-180 gmsStandard temp.: 90-130 gmsTolerance range: ± 7.5%, measuredaccording to ISO 9713 | L-Clip:Mini perm .: 110-130 gmsMini temp.:70-90 gmsStandard perm.: 150-180 gmsStandard temp.: 90-130 gmsYasargil-Clip:Mini perm.: 110-130 gmsMini temp.:70-90 gmsStandard perm.: 150-200 gmsStandard temp.: 90-130 gmsTolerance range: ± 7.5%, measured according toISO 9713 | The closing force of theD-Clip is identical toclosing force of the L-Clipand lies in the range ofYasargil-Clip closingforce.SubstantiallyEquivalent |
| Materials | Titanium ISO 5832-2Ti6Al4V ISO 5832-3 | L-Clip:Titanium ISO 5832-2Ti6Al4V ISO 5832-3Yasargil-Clip:Ti6Al4V ISO 5832-3Cobalt alloy Phynox ISO 5832-7 | D-Clip is manufacturedfrom the identicalmaterials than theTitanium Versions of theL-Clip and Yasargil Clip.SubstantiallyEquivalent |
| Energy source | No energy source needed | No energy source needed | No difference.SubstantiallyEquivalent |
| Principle of operation | Inside the body of the clip is a springthat creates tension and through thistension the necessary closing force forocclusion. With an applier, the jaws canbe opened, closed and guided forocclusion. | Inside the body of the clip is a spring that createstension and through this tension the necessaryclosing force for occlusion. With an applier, thejaws can be opened, closed and guided forocclusion. | No difference.SubstantiallyEquivalent |
| Technological characteristics | K081489 | Change discussion | |
| Peter Lazic GmbH | Peter Lazic GmbH | ||
| Lazic D-Aneurysm Clip Appliers | Lazic L-Aneurysm Clip Appliers /Yasargil Aneurysm Clip Appliers | ||
| Design | One version with double actionhandles and one with memory effect. | One version with double actionhandles and one with memory effect. | Versions with double action handlesand with memory effect of the D-ClipAppliers have identical shankscompared to those of the L-Clip andthe Yasargil Clip.The difference of the three Applierslies in the jaw design. When theshanks of the D-Clip Appliers and theYasargil Clip Appliers are compressed,the jaws are closing making the clipopen up. When the shanks of the L-Clip Appliers are compressed the jawsare opening up, making the clip openup. |
| Substantially Equivalent | |||
| Materials | 1.4021 / ASTM A 276 / AISI 420A;1.4305 / AISI 303;1.4310 / AISI 301;3.7165 / ASTM F 136 / ISO 5832-3;Nitinol / ASTM F0263-05 | 1.4021 / ASTM A 276 / AISI 420A;1.4305 / AISI 303;1.4310 / AISI 301;3.7165 / ASTM F 136 / ISO 5832-3;Nitinol / ASTM F0263-05 | D-Clip Appliers are manufacturedfrom the identical materials than theTitanium Versions of the L-Clip andYasargil Clip Appliers.Substantially Equivalent |
| Energy source | No energy source needed | No energy source needed | No differencesSubstantially Equivalent |
{6}------------------------------------------------
Peter Lazic GmbH D-Aneurysm-Clip & D-Aneurysm Clip Applier
510(k) Premarket Notification
Image /page/6/Picture/2 description: The image shows a logo for Peter Lazic Microsurgical Innovations. The logo features a stylized letter "L" in gray, with a circular cutout in the upper portion. To the right of the "L" is the name "PETER LAZIC" in a sans-serif font, with "PETER" in gray and "LAZIC" in yellow. Below the name, the words "MICROSURGICAL INNOVATIONS" are written in a smaller, sans-serif font.
{7}------------------------------------------------
Image /page/7/Picture/1 description: The image shows the logo for Peter Lazic Microsurgical Innovations. The logo features a large, gray letter 'P' with a circular cutout in the upper right corner. To the right of the 'P' is the name "PETER LAZIC" in a combination of gray and yellow text. Below the name, the words "MICROSURGICAL INNOVATIONS" are written in a smaller, gray font.
4.5.2 Technological characteristics of D-Aneurysm Clip Applier
{8}------------------------------------------------
Image /page/8/Picture/1 description: The image shows the logo for Peter Lazic Microsurgical Innovations. The logo features a stylized gray letter "L" with a circular cutout, followed by the name "PETER LAZIC" in a stacked format. The "LAZIC" portion is highlighted with a yellow rectangle behind it. Below the name, the words "MICROSURGICAL INNOVATIONS" are written in a smaller, sans-serif font.
| Technological characteristics | K081489 | Change discussion | |
|---|---|---|---|
| Peter Lazic GmbH | Peter Lazic GmbH | ||
| Lazic D-Aneurysm Clip Appliers | Lazic L-Aneurysm Clip Appliers /Yasargil Aneurysm Clip Appliers | ||
| Applying Technique | Compressing clip shanks to open theclip from outer side of shanks.Image: Clip Applier | L-Clip Appliers: Compressing clipshanks to open the clip from inside ofshanks.Image: L-Clip ApplierYasargil Aneurysm Clip Appliers:Compressing clip shanks to open theclip from outer side of shanks.Image: Yasargil Aneurysm Clip Applier | The applying technique of D-ClipAppliers and Yasargil Clip Appliers isidentical. Compressing the clip shankscloses the jaws and opens the D-cliprespective Yasargil Clip.Compressing the clip shanks of the L-Clip Appliers opens the jaws and thatopens the L-Clip.Substantially Equivalent |
{9}------------------------------------------------
Image /page/9/Picture/1 description: The image shows the logo for Peter Lazic Microsurgical Innovations. The logo features a stylized letter "L" in gray, with a circular cutout at the top. The words "PETER LAZIC" are printed in a smaller font size and are placed to the left of a yellow rectangle. Below the rectangle, the words "MICROSURGICAL INNOVATIONS" are printed in a smaller, gray font. The overall design is modern and professional.
5 Performance Standards
5.1 D-Aneurysm-Clips
| Test | Test Method Summary | Results |
|---|---|---|
| Microbiologicalperformancequalification ofgamma radiationsterilization | 10 samples of the worst case clipswere tested. The verification dosewas determined based on theaverage bioburden of three lots as$5,2\pm0,52$ kGy. The 10 samples weregamma irradiated. | An average bioburden of 2,0cfu/sample was determined aftersterilization. The tests indicatedthat the microbial contaminationwas inactivated by the irradiation of$5,40$ kGy $\pm$ $3,7$ %. Therefore, thegamma irradiation method ensureseffective conditions with a sterilityassurance level (SAL) <10-6 for thesterilization of the devices byapplication of a minimum dose of$25$ kGy.The tests were conducted on aworst case clip. The worst caseanalysis covers the predicate deviceas well as the D-Clip. The resultsshow that it is possible to sterilizethe D-Clip with an identicalsterilization dose than the predicatedevice. |
| Validation ofthe sterilebarriersystem (SBS)) | A validation of the sterile barriersystem has been conducted bythe responsible service provider. Abasic stability study of the emptySBS as well as stability studiesand performance testing of theSBS with products was conducted. | The requirements imposed onmicrobial barrier properties for thebasic SBS were met successfully forthe packaging material. Shelf life ofthe sterile barrier system after 5years accelerated aging wasconfirmed successfully. |
| MRI Safety | The devices had been tested in astatic magnetic field of 1,5 and 3-Tesla and a maximum spatialgradient magnetic field of 4,000-Gaus/cm. | The testing demonstrated that theD-Clip and the predicate device areMR Conditional. They will notpresent an additional hazard or riskto a patient undergoing an MRIprocedure in a static magnetic fieldof 1.5- Tesla and 3-Tesla, with amaximum spatial gradient magneticfield of 4,000-Gauss/cm. Amaximum whole body averagedspecific absorption rate of 2-W/kgfor 15 minutes of scanning in theNormal Operating Mode wasmeasured. These parameters areequivalent for the D-Clip and the L-Clip. The D-Clip is expected toproduce a maximum temperaturerise of 1,7°C after 15-minutes ofcontinuous scanning. The L-Clip isexpected to produce a maximumtemperature rise of 1,8°C after 15-minutes of continuous scanning.The D-Clip extends approximately10-mm from this implant whenimaged using a gradient echo pulse |
| sequence and a 3-Tesla MR system,while the L-Clip extendsapproximately 15-mm.The results for the D-Clipoutperform those for the predicatedevice. | ||
| LAL endotoxin test | The samples were rinsed withsterile, pyrogen free wateraccording to the product- andmethod-specific validation. Then,the rinsing fluids were investigatedfor the presence of endotoxins withthe quantitative LAL endotoxin test.Sterile, pyrogen free water wasused as negative control, FDAproved endotoxin standard aspositive control. | Endotoxins were not detected in therinsing fluids of the investigatedsamples.The test has been performed on thepredicate device. Since the devicesare manufactured with similarmanufacturing processes andidentical materials the results aredeemed applicable. |
| Degradation of closing force tests | The closing force of the clip shall bemeasured before and after 10maximum opening of the clip withthe recommended applier. Thereduction of the closing force shallbe less than 5% of the nominalclosing force. | The tested D-Clips did fulfill therequirements of ISO 9713. The testresults of the L-Clips and theYasargil Clips fulfilled therequirements as well.The closing force is deemedequivalent. |
{10}------------------------------------------------
Peter Lazic GmbH D-Aneurysm-Clip & D-Aneurysm Clip Applier
510(k) Premarket Notification
Image /page/10/Picture/2 description: The image shows a logo for Peter Lazic Microsurgical Innovations. The logo features a gray letter "P" with a circular cutout in the upper right corner. Below the "P" is the name "PETER LAZIC," with "PETER" in gray and "LAZIC" in yellow. Underneath the name, in smaller gray font, are the words "MICROSURGICAL INNOVATIONS."
5.2 D-Aneurysm Clip Appliers
| Test | Test Method Summary | Results |
|---|---|---|
| Microbiological efficiency control ofthe automated cleaning anddisinfection method | For determination of the cleaningefficiency selected referenceproducts were contaminated with"British Soil" containing spores ofBacillus atrophaeus. Fordetermination of the disinfectionefficiency, selected referenceproducts were contaminated with asuspension of the high-resistanttest organism Mycobacteriumterrae. Then, according to theinstructions of the sponsor theautomated cleaning and disinfectionmethod was performed on threecontaminated reference products.Afterwards, the reduction of the | A worst-case selection has beenconducted identifying severalcritical components. A dummydevice including the criticalcomponents was manufactured andused for all reprocessingvalidations.The concentration of the used testorganisms Bacillus atrophaeus wasreduced by the automated cleaningmethod of at least 5.2 log steps.The concentration of the used testorganism Mycobacterium terraewas reduced of at least 6.8 logsteps. |
| test organisms was determined. | The tests had been conducted withthe predicate device. The beforedescribed worst-case dummy hasmore or identical disadvantageousproperties with regard to productgeometry and surface structure.Therefore the D-Clip appliers aredeemed to be able to be cleanedand disinfected equivalent to thepredicate device. | |
| Microbiological efficiency control ofthe manual cleaning anddisinfection method | For determination of the cleaningefficiency selected referenceproducts were contaminated with"British Soil" containing spores ofBacillus atrophaeus. Fordetermination of the disinfectionefficiency, selected referenceproducts were contaminated with asuspension of the high-resistanttest organism Mycobacteriumterrae. Then, according to theinstructions of the sponsor themanual cleaning and disinfectionmethod was performed on threecontaminated reference products.Afterwards, the reduction of thetest organisms was determined. | Visible remains of thecontamination medium were notdetected on the reference devicesafter performance of the manualcleaning method. The concentrationof the used test organisms Bacillusatrophaeus was reduced by themanual cleaning method of at least4.8 log steps. The concentration ofthe used test organismMycobacterium terrae was reducedof at least 5.3 log steps.The tests had been conducted withthe predicate device. The beforedescribed worst-case dummy hasmore or identical disadvantageousproperties with regard to productgeometry and surface structure.Therefore the D-Clip appliers aredeemed to be able to be cleanedand disinfected equivalent to thepredicate device. |
| Microbiological efficiency control ofsteam sterilization | Three qualification runs with threeinoculated test samples each wereconducted. The first and third runwas conducted with sterilizationtemperature 121°C, exposure time10min (half cycle) and the secondrun with sterilization temperature132°C, exposure time 1,5min (halfcycle). For each qualification runone non-exposed process challengedevice per type was used as controlfor spore viability.For inoculation the most difficultparts for steam access were used.The Type A1 challenge deviceswere inoculated at the joint of theforceps, at the annular gap of theshaft and at the gap betweenspring and handle. The Type A2challenge devices were inoculatedat the joint of the forceps, at theannular gap of the shaft and at thejoint of the handle. The Type A3challenge devices were inoculatedat the front, the central and theback of the cross armed joint. | All tested devices in threeindependent half cycle qualificationruns were free of microbial growth.The conducted tests indicate thatthe products of the product groupApplying Forceps of Peter Lazic canbe steam-sterilized with a sufficientspore log reduction of >12 by useof standard sterilization parameters(fractioned vacuum procedure,121°C, 20 min, and 134°C, 4min).The tests had been conducted withthe predicate device. The beforedescribed worst-case dummy hasmore or identical disadvantageousproperties with regard to steamaccess, steam permeability andproduct geometry than the D-Clipappliers. Therefore the D-Clipappliers are deemed to be able tobe sterilized equivalent to thepredicate device. |
| Bending test Memory material instraight condition at the beginningof use/ -without wash-out andcleaning cycles- | The test was determined to showvia three point bending procedurehow much force is necessary tobend the shaft. The tests had beenconducted on the raw material withmechanical force.First the force to bend the productwas measured as well as themaximum radius and angle. Then | About 40 N were necessary todeform the shaft, meaning it takesforce to deform the shaft, but theshaft can be deformed withoutmuch effort. The material can bebend by hand without much effort.The test also shows that thematerial properties have notchanged after a certain time. |
| the material was bend 100 times, | The force required to bend theshaft was in a similar range after | |
| measuring the bending force againafter 100 bendings. | 100 bends. This means thatbending has no effect on thematerial and its properties.Therefore, the material has nonegative effect on the device. | |
| Defining the bending cycles topossible function restrictions | The aim of the test is to find outwhether applying forceps withmemory shaft shows possiblefunctional limitations after bendingsome times. 10 applying forcepsare bent several times withoutheating and regenerating the shaftin between. The bending is donemanually and without exactdetermination of the bending angle,as it is the case in operations.The procedure is as follows, theappliers are checked for functionsin their original steps with zerobendings. Then the shaft is bentover 90° and the appliers arechecked for their functions. In thenext step the shaft is straightened,and the appliers are checked fortheir functions. 30 repetitions areperformed (15 times 90° bending,15 times straightening) | The results were positive withoutexception. After 30 repetitions allapplying forceps were stillfunctioning as intended. Thebending did not have an influenceon the function of the applier. Theystill fulfilled the technicalrequirements. |
| Behavior of the D-Clip Applyingforceps after repeated use andreprocessing | For this test 10 D-Clips applierswere produced. In the test the useand reprocessing of the device wassimulated. Therefore, the Itemswere bend 10 times, then cleanedin an ultrasonic bath(simulating a manual cleaning)and then sterilized at 134°C for 12minutes. This procedure wasperformed 100 times. | All 10 tested Memory D-Aneurysm-Clip Appliers showed full functionafter the maximum tested 100cycles. All Memory-Clip Applierswere tested according To thetesting for product release andfulfilled the specification. Therefore,we can tell that the bending of theshaft within 100 times max.bending does not have effects onthe function of the D-Clip Memoryapplier. |
{11}------------------------------------------------
Peter Lazic GmbH D-Aneurysm-Clip & D-Aneurysm Clip Applier
510(k) Premarket Notification
Image /page/11/Picture/2 description: The image contains a logo for Peter Lazic Microsurgical Innovations. The logo features a stylized letter "L" in gray, with the words "PETER LAZIC" in a smaller font below it. To the right of "LAZIC" is a yellow rectangle. Below the letter and name is the text "MICROSURGICAL INNOVATIONS" in a smaller, sans-serif font. The overall design is clean and modern, suggesting a professional and innovative company.
{12}------------------------------------------------
Peter Lazic GmbH D-Aneurysm-Clip & D-Aneurysm Clip Applier
510(k) Premarket Notification
Image /page/12/Picture/2 description: The image shows the logo for Peter Lazic Microsurgical Innovations. The logo features a stylized letter "P" in gray, with the words "PETER LAZIC" in a smaller font below it. The word "LAZIC" is highlighted in yellow. Below the name, the words "MICROSURGICAL INNOVATIONS" are written in a smaller, gray font. The logo is clean and modern, suggesting a focus on precision and innovation.
6 Sterilization
Lazic's D-Aneurysm-Clips are available in sterile conditions. Lazic's D-Aneurysm Clip Appliers are available in non-sterile conditions only.
{13}------------------------------------------------
Image /page/13/Picture/1 description: The image shows the logo for Peter Lazic Microsurgical Innovations. The logo features a stylized letter 'P' in gray, with a small white circle cut out of the top right corner. To the right of 'P' is the name 'PETER LAZIC' with 'PETER' stacked on top of 'LAZIC'. The word 'LAZIC' is in yellow. Below the name is the text 'MICROSURGICAL INNOVATIONS' in a smaller, sans-serif font.
Conclusion 7
The modification of Lazic's D-Aneurysm-Clips raises no new questions of safety and effectiveness. It combines the design of the L-Clip with the application of the Yasargil Aneurysm Clip. The same applies to Lazic's D-Aneurysm Clip Appliers.
Therefore, the D-Aneurysm-Clips and the D-Aneurysm Clip Appliers are substantially equivalent to the predicate devices.
{14}------------------------------------------------
Please wait...
If this message is not eventually replaced by the proper contents of the document, your PDF viewer may not be able to display this type of document.
You can upgrade to the latest version of Adobe Reader for Windows®, Mac, or Linux® by visiting http://www.adobe.com/go/reader_download.
For more assistance with Adobe Reader visit http://www.adobe.com/go/acrreader.
Windows is either a registered trademark of Microsoft Corporation in the United States and/or other countries. Mac is a trademark of Apple Inc., registered in the United States and other countries. Linux is the registered trademark of Linus Torvalds in the U.S. and other countries.
§ 882.5200 Aneurysm clip.
(a)
Identification. An aneurysm clip is a device used to occlude an intracranial aneurysm (a balloonlike sac formed on a blood vessel) to prevent it from bleeding or bursting.(b)
Classification. Class II (performance standards).