(386 days)
Not Found
No
The device description and performance studies focus on the mechanical properties, sterilization, and safety of surgical clips and appliers, with no mention of AI or ML.
Yes
The device is intended for the permanent or temporary occlusion of cerebral aneurysms and intracranial blood vessels, which directly addresses a pathological condition to restore health.
No
The device, D-Aneurysm-Clips and D-Aneurysm Clip Appliers, is described as being for "permanent occlusion of cerebral aneurysms" and "temporary occlusion of intracranial blood vessels and cerebral aneurysms." This indicates a therapeutic, interventional function rather than a diagnostic one. The performance studies focus on sterility, material properties, and functionality of the clips and appliers, not on diagnostic accuracy.
No
The device description clearly details physical components (clips and appliers) made of materials and designed for physical interaction with the body. The performance studies also focus on the physical properties and sterilization of these hardware components. There is no mention of software as a component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the devices are for the "permanent occlusion of cerebral aneurysms" and "temporary occlusion of intracranial blood vessels and cerebral aneurysms." This describes a surgical intervention performed directly on the patient's body.
- Device Description: The description details physical clips and appliers used for surgical procedures.
- Anatomical Site: The anatomical site is "Cerebral, Intracranial blood vessels," which are internal structures of the body.
- Performance Studies: The performance studies focus on aspects relevant to implantable or surgical devices, such as sterilization, sterile barrier integrity, MRI safety, closing force, cleaning/disinfection efficacy, and material bending properties. These are not typical performance metrics for IVD devices.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (like blood, urine, tissue), detecting specific analytes, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical tool used within the body for a therapeutic purpose (occlusion of blood vessels).
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
HCH, HCI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracranial blood vessels and cerebral aneurysms
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained surgeons thoroughly familiar with the surgical technique and use of these medical devices.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Microbiological performance qualification of gamma radiation sterilization
- Test Method Summary: 10 samples of the worst case clips were tested. The verification dose was determined based on the average bioburden of three lots as 5,2 +/- 0,52 kGy. The 10 samples were gamma irradiated.
- Results: An average bioburden of 2,0 cfu/sample was determined after sterilization. The tests indicated that the microbial contamination was inactivated by the irradiation of 5,40 kGy +/- 3,7 %. Therefore, the gamma irradiation method ensures effective conditions with a sterility assurance level (SAL) 12 by use of standard sterilization parameters (fractioned vacuum procedure, 121°C, 20 min, and 134°C, 4min). The tests had been conducted with the predicate device. The before described worst-case dummy has more or identical disadvantageous properties with regard to steam access, steam permeability and product geometry than the D-Clip appliers. Therefore the D-Clip appliers are deemed to be able to be sterilized equivalent to the predicate device.
Bending test Memory material in straight condition at the beginning of use/ -without wash-out and cleaning cycles-
- Test Method Summary: The test was determined to show via three point bending procedure how much force is necessary to bend the shaft. The tests had been conducted on the raw material with mechanical force. First the force to bend the product was measured as well as the maximum radius and angle. Then the material was bend 100 times, measuring the bending force again after 100 bendings.
- Results: About 40 N were necessary to deform the shaft, meaning it takes force to deform the shaft, but the shaft can be deformed without much effort. The material can be bend by hand without much effort. The test also shows that the material properties have not changed after a certain time. The force required to bend the shaft was in a similar range after 100 bends. This means that bending has no effect on the material and its properties. Therefore, the material has no negative effect on the device.
Defining the bending cycles to possible function restrictions
- Test Method Summary: The aim of the test is to find out whether applying forceps with memory shaft shows possible functional limitations after bending some times. 10 applying forceps are bent several times without heating and regenerating the shaft in between. The bending is done manually and without exact determination of the bending angle, as it is the case in operations. The procedure is as follows, the appliers are checked for functions in their original steps with zero bendings. Then the shaft is bent over 90° and the appliers are checked for their functions. In the next step the shaft is straightened, and the appliers are checked for their functions. 30 repetitions are performed (15 times 90° bending, 15 times straightening)
- Results: The results were positive without exception. After 30 repetitions all applying forceps were still functioning as intended. The bending did not have an influence on the function of the applier. They still fulfilled the technical requirements.
Behavior of the D-Clip Applying forceps after repeated use and reprocessing
- Test Method Summary: For this test 10 D-Clips appliers were produced. In the test the use and reprocessing of the device was simulated. Therefore, the Items were bend 10 times, then cleaned in an ultrasonic bath (simulating a manual cleaning) and then sterilized at 134°C for 12 minutes. This procedure was performed 100 times.
- Results: All 10 tested Memory D-Aneurysm-Clip Appliers showed full function after the maximum tested 100 cycles. All Memory-Clip Appliers were tested according To the testing for product release and fulfilled the specification. Therefore, we can tell that the bending of the shaft within 100 times max. bending does not have effects on the function of the D-Clip Memory applier.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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-Clip
Yasargil Aneurysm Clip
L-Clip Appliers
Yasargil Aneurysm Clip Appliers |
|-----------------------------------------|----------------------------------------------------------------------------------------|
| Trade Name of modified device: | D-Aneurysm-Clips
D-Aneurysm Clip Appliers |
| Common Name: | Aneurysm Clip
Aneurysm Clip Appliers |
| Device Classification Name: | Aneurysm Clip
Aneurysm Clip Appliers |
Classification 2
Our aneurysm clips and aneurysm clip appliers are classified as follows:
| Device: | D-Aneurysm-Clips | D-Aneurysm Clip Appliers |
|---|---|---|
| Device | ||
| description: | Aneurysm clip | Aneurysm clip applier |
| Medical | ||
| Specialty: | Neurology | Neurology |
| Product Code: | HCH | HCI |
| Regulation | ||
| Number: | 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-Clip | ||
| Yasargil Aneurysm Clip | K081489 | Peter Lazic GmbH | |
| D-Aneurysm Clip Appliers | L-Clip Appliers | ||
| Yasargil 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 the | ||
| applying forceps | |||
| Image: D-clip | L-clip: Inner application by the applying forceps | ||
| Image: L-clip | |||
| Yasargil: Outer application by the applying | |||
| forceps | |||
| Image: Yasargil clip | Compared to the L-clip | ||
| the only difference is that | |||
| the D-clip is applied from | |||
| the outside. All other | |||
| design features are | |||
| identical. For both | |||
| devices the same spring | |||
| is used. Meaning they | |||
| even share a semi- | |||
| finished good. | |||
| Compared to the Yasargil | |||
| clip the D-clip has a | |||
| similar outer application, | |||
| but different spring | |||
| design. | |||
| Substantially | |||
| Equivalent | |||
| --- | 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 gms | ||
| Mini temp.: 70-90 gms | |||
| Standard perm.: 150-180 gms | |||
| Standard temp.: 90-130 gms | |||
| Tolerance range: ± 7.5%, measured | |||
| according to ISO 9713 | L-Clip: | ||
| Mini perm .: 110-130 gms | |||
| Mini temp.:70-90 gms | |||
| Standard perm.: 150-180 gms | |||
| Standard temp.: 90-130 gms | |||
| Yasargil-Clip: | |||
| Mini perm.: 110-130 gms | |||
| Mini temp.:70-90 gms | |||
| Standard perm.: 150-200 gms | |||
| Standard temp.: 90-130 gms | |||
| Tolerance range: ± 7.5%, measured according to | |||
| ISO 9713 | The closing force of the | ||
| D-Clip is identical to | |||
| closing force of the L-Clip | |||
| and lies in the range of | |||
| Yasargil-Clip closing | |||
| force. | |||
| Substantially | |||
| Equivalent | |||
| Materials | Titanium ISO 5832-2 | ||
| Ti6Al4V ISO 5832-3 | L-Clip: | ||
| Titanium ISO 5832-2 | |||
| Ti6Al4V ISO 5832-3 | |||
| Yasargil-Clip: | |||
| Ti6Al4V ISO 5832-3 | |||
| Cobalt alloy Phynox ISO 5832-7 | D-Clip is manufactured | ||
| from the identical | |||
| materials than the | |||
| Titanium Versions of the | |||
| L-Clip and Yasargil Clip. | |||
| Substantially | |||
| Equivalent | |||
| Energy source | No energy source needed | No energy source needed | No difference. |
| Substantially | |||
| Equivalent | |||
| Principle of operation | Inside the body of the clip is a spring | ||
| that creates tension and through this | |||
| tension the necessary closing force for | |||
| occlusion. With an applier, the jaws can | |||
| be opened, closed and guided for | |||
| occlusion. | Inside the body of the clip is a spring that creates | ||
| tension and through this tension the necessary | |||
| closing force for occlusion. With an applier, the | |||
| jaws can be opened, closed and guided for | |||
| occlusion. | No difference. | ||
| Substantially | |||
| Equivalent | |||
| 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 action | ||
| handles and one with memory effect. | One version with double action | ||
| handles and one with memory effect. | Versions with double action handles | ||
| and with memory effect of the D-Clip | |||
| Appliers have identical shanks | |||
| compared to those of the L-Clip and | |||
| the Yasargil Clip. |
The difference of the three Appliers
lies in the jaw design. When the
shanks of the D-Clip Appliers and the
Yasargil Clip Appliers are compressed,
the jaws are closing making the clip
open up. When the shanks of the L-
Clip Appliers are compressed the jaws
are opening up, making the clip open
up. |
| | | | 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 manufactured
from the identical materials than the
Titanium Versions of the L-Clip and
Yasargil Clip Appliers.
Substantially Equivalent |
| Energy source | No energy source needed | No energy source needed | No differences
Substantially 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 the | ||
| clip from outer side of shanks. | |||
| Image: Clip Applier | L-Clip Appliers: Compressing clip | ||
| shanks to open the clip from inside of | |||
| shanks. | |||
| Image: L-Clip Applier | |||
| Yasargil Aneurysm Clip Appliers: | |||
| Compressing clip shanks to open the | |||
| clip from outer side of shanks. | |||
| Image: Yasargil Aneurysm Clip Applier | The applying technique of D-Clip | ||
| Appliers and Yasargil Clip Appliers is | |||
| identical. Compressing the clip shanks | |||
| closes the jaws and opens the D-clip | |||
| respective Yasargil Clip. | |||
| Compressing the clip shanks of the L- | |||
| Clip Appliers opens the jaws and that | |||
| opens 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 |
|---|---|---|
| Microbiological | ||
| performance | ||
| qualification of | ||
| gamma radiation | ||
| sterilization | 10 samples of the worst case clips | |
| were tested. The verification dose | ||
| was determined based on the | ||
| average bioburden of three lots as | ||
| $5,2\pm0,52$ kGy. The 10 samples were | ||
| gamma irradiated. | An average bioburden of 2,0 | |
| cfu/sample was determined after | ||
| sterilization. The tests indicated | ||
| that the microbial contamination | ||
| was inactivated by the irradiation of | ||
| $5,40$ kGy $\pm$ $3,7$ %. Therefore, the | ||
| gamma irradiation method ensures | ||
| effective conditions with a sterility | ||
| assurance level (SAL) 12 by use | ||
| of standard sterilization parameters | ||
| (fractioned vacuum procedure, | ||
| 121°C, 20 min, and 134°C, 4min). | ||
| The tests had been conducted with | ||
| the predicate device. The before | ||
| described worst-case dummy has | ||
| more or identical disadvantageous | ||
| properties with regard to steam | ||
| access, steam permeability and | ||
| product geometry than the D-Clip | ||
| appliers. Therefore the D-Clip | ||
| appliers are deemed to be able to | ||
| be sterilized equivalent to the | ||
| predicate device. | ||
| Bending test Memory material in | ||
| straight condition at the beginning | ||
| of use/ -without wash-out and | ||
| cleaning cycles- | The test was determined to show | |
| via three point bending procedure | ||
| how much force is necessary to | ||
| bend the shaft. The tests had been | ||
| conducted on the raw material with | ||
| mechanical force. | ||
| First the force to bend the product | ||
| was measured as well as the | ||
| maximum radius and angle. Then | About 40 N were necessary to | |
| deform the shaft, meaning it takes | ||
| force to deform the shaft, but the | ||
| shaft can be deformed without | ||
| much effort. The material can be | ||
| bend by hand without much effort. | ||
| The test also shows that the | ||
| material properties have not | ||
| changed after a certain time. | ||
| the material was bend 100 times, | The force required to bend the | |
| shaft was in a similar range after | ||
| measuring the bending force again | ||
| after 100 bendings. | 100 bends. This means that | |
| bending has no effect on the | ||
| material and its properties. | ||
| Therefore, the material has no | ||
| negative effect on the device. | ||
| Defining the bending cycles to | ||
| possible function restrictions | The aim of the test is to find out | |
| whether applying forceps with | ||
| memory shaft shows possible | ||
| functional limitations after bending | ||
| some times. 10 applying forceps | ||
| are bent several times without | ||
| heating and regenerating the shaft | ||
| in between. The bending is done | ||
| manually and without exact | ||
| determination of the bending angle, | ||
| as it is the case in operations. |
The procedure is as follows, the
appliers are checked for functions
in their original steps with zero
bendings. Then the shaft is bent
over 90° and the appliers are
checked for their functions. In the
next step the shaft is straightened,
and the appliers are checked for
their functions. 30 repetitions are
performed (15 times 90° bending,
15 times straightening) | The results were positive without
exception. After 30 repetitions all
applying forceps were still
functioning as intended. The
bending did not have an influence
on the function of the applier. They
still fulfilled the technical
requirements. |
| Behavior of the D-Clip Applying
forceps after repeated use and
reprocessing | For this test 10 D-Clips appliers
were produced. In the test the use
and reprocessing of the device was
simulated. Therefore, the Items
were bend 10 times, then cleaned
in an ultrasonic bath
(simulating a manual cleaning)
and then sterilized at 134°C for 12
minutes. This procedure was
performed 100 times. | All 10 tested Memory D-Aneurysm-
Clip Appliers showed full function
after the maximum tested 100
cycles. All Memory-Clip Appliers
were tested according To the
testing for product release and
fulfilled the specification. Therefore,
we can tell that the bending of the
shaft within 100 times max.
bending does not have effects on
the function of the D-Clip Memory
applier. |
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
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