(206 days)
No
The document describes a mechanical surgical instrument (clip applier) and its coating, with no mention of software, data processing, or AI/ML terms.
No.
The device description and intended use indicate that the device is an applier for aneurysm clips, which is a surgical instrument, not a therapeutic device. It is used to apply devices (aneurysm clips) that perform the therapy, but the applier itself does not provide therapy.
No
The device is described as an applier used to apply aneurysm clips, which is a surgical tool, not a diagnostic one.
No
The device description explicitly states the device is manufactured from stainless steel and is a physical instrument used to apply aneurysm clips. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "open, close and apply permanent/temporary Aesculap YASARGIL titanium aneurysm clips." This describes a surgical instrument used directly on a patient during a procedure.
- Device Description: The description details a surgical tool made of stainless steel with specific features for handling aneurysm clips.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) in vitro (outside the body) to provide information about a patient's health. IVDs are typically used for diagnosis, monitoring, or screening based on laboratory analysis.
Therefore, this device is a surgical instrument, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The slim clip applier is used to open, close and apply permanent/temporary Aesculap YASARGIL titanium aneurysm clips.
Product codes (comma separated list FDA assigned to the subject device)
HCI
Device Description
The Aesculap Slim Clip Appliers are manufactured from stainless steel and are available in various lengths, jaw angulations, with or without latches. This submission intends to add a coating to the previously cleared clip appliers. Each clip applier is individually laser marked with the type of clip designated for use. In addition, at least one identification plug is located within one of the handles to aid in identifying the aneurysm clip designation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Bench testing results demonstrate that the Aesculap Slim Clip Applier is substantially equivalent to the Aesculap Slim Clip Appliers currently on the market. The bench testing of clip appliers demonstrates that the Aesculap Slim Clip Applier forceps perform as intended and are as safe, effective, and perform as well as the predicate devices.
Performance Test Completed: Verification test for clip opening
Test purpose: To verify the minimum opening width of aneurysm clips meets the requirement.
Results: Pass
Conclusion: The Aesculap Slim Clip Appliers meet the test acceptance criteria.
Biocompatibility testing was also performed:
Cytotoxicity: Test articles were extracted for 24 hours per ISO 10993-5. All test articles exhibited a reactivity grade of 0. Positive and negative controls behaved as anticipated. Conclusion: Non-cytotoxic.
Sensitization: The test article extracts showed no evidence of causing delayed dermal contact sensitization in the guinea pig. The test article was not considered a sensitizer in the guinea pig maximization test. Conclusion: Non-sensitive.
Pyrogenicity: The purpose of this assessment is to determine if a test article extract induces a pyrogenic response following intravenous injection in rabbits (temperature rise below 0.5 °C indicates the absence of pyrogens). Based on the assessment per ISO 10993-11, the materials are non-pyrogenic. Conclusion: Non-pyrogenic.
Irritation: All animals appeared normal throughout the study. The test article met the requirements of the test since the difference between each test article extract overall mean score and corresponding control extract overall mean score was 0.0 for both the SC and SO test article extracts. Conclusion: Normal.
Systemic Toxicity: There was no mortality or evidence of systemic toxicity from the extracts injected into mice. Each test article extract met the requirements of the study. Conclusion: Non-Toxic.
Hemolysis: The test article extract was tested in vitro. The hemolytic index for the test article extract was 0.0% and the test article extract was considered non-hemolytic. Conclusion: Non-Hemolytic.
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.
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
§ 882.4175 Aneurysm clip applier.
(a)
Identification. An aneurysm clip applier is a device used by the surgeon for holding and applying intracranial aneurysm clips.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
December 13, 2021
Aesculap, Inc. Paul Amudala Senior Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K211572
Trade/Device Name: Aesculap Slim Clip Applier Regulation Number: 21 CFR 882.4175 Regulation Name: Aneurysm Clip Applier Regulatory Class: Class II Product Code: HCI Dated: November 9, 2021 Received: November 10, 2021
Dear Paul Amudala:
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 located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions 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
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 postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Naira Muradyan, Ph.D., Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211572
Device Name Aesculap Slim Clip Applier
Indications for Use (Describe)
The slim clip applier is used to open, close and apply permanent/temporary Aesculap Y ASARGIL titanium aneurysm clips.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(K) SUMMARY
[as required by 21 CFR §807.92(c)]
K211572
| DATE PREPARED: | 13 December 2021 |
|---|---|
| SUBMITTER: | Aesculap®, Inc. |
| 3773 Corporate Parkway | |
| Center Valley, PA 18034 | |
| +1 800-258-1946 | |
| CONTACT: | Paul Amudala |
| Sr. Regulatory Affairs Specialist | |
| 610-984-9303 (phone) | |
| 610-417-0839 (mobile) | |
| 610-791-6882 (fax) | |
| TRADE NAME: | Aesculap Slim Clip Applier |
| COMMON NAME: | Aneurysm Clip Applier |
| DEVICE CLASSIFICATION: | Class II |
| REGULATION NUMBER: | 21 CFR 882.4175 |
| PRODUCT CODE: | HCI |
| REVIEW PANEL: | Neurology |
| PRIMARY PREDICATE | |
| DEVICE: | Aesculap Slim Clip Applier (K180914; April 17, 2018) |
| REFERENCE DEVICES: | Aesculap Slim Clip Applier (K173271; November 10, 2017) |
| Yasargil, Caspar, Vario Clip Appliers (K940970; January | |
| 24, 1995) |
DEVICE DESCRIPTION
The Aesculap Slim Clip Appliers are manufactured from stainless steel and are available in various lengths, jaw angulations, with or without latches. This submission intends to add a coating to the previously cleared clip appliers. Each clip applier is individually laser marked with the type of clip designated for use. In addition, at least one identification plug is located within one of the handles to aid in identifying the aneurysm clip designation.
INDICATIONS FOR USE
The slim clip applier is used to open, close and apply permanent/temporary Aesculap YASARGIL titanium aneurysm clips.
4
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
The Aesculap Slim Clip Applier forceps are substantially equivalent to the predicate Aesculap Slim Clip Applier forceps. The intended use, fundamental scientific principles, and base materials of the clip appliers remain unchanged since last clearance. This submission intends to add a coating to the previously cleared clip appliers.
| | Subject Device
Aesculap Slim Clip
Applier | Predicate
Aesculap Slim Clip
Applier | Reference Device
Aesculap Slim Clip
Applier | Reference Device
Yasargil, Caspar,
Vario Clip Appliers |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| | K211572 | K180914 | K173271 | K940970 (Vario
functionality reference
only) |
| Indications for
Use | The slim clip applier
is used to open, close
and apply permanent/
temporary Aesculap
YASARGIL titanium
aneurysm clips. | The Aesculap Slim
Clip Applier forceps
are used for
opening, closing,
and applying
Aesculap
YASARGIL
aneurysm clips. | The Aesculap Slim
Clip Applier forceps
are used for
opening, closing,
and applying
Aesculap
YASARGIL
aneurysm clips. | The Aesculap Titanium
Aneurysm clip appliers
are used for holding and
applying intracranial
titanium aneurysm clips. |
| Clip Applier: | | | | |
| Base Material | Stainless Steel | Same | Same | Titanium |
| Type | Standard & Mini &
Vario | Standard & Mini | Standard & Mini | Standard & Mini &
Vario |
| Length | 70mm, 90mm, 110mm | 50mm to 110mm,
120mm and 130mm | 50mm to 110mm | 90mm |
| Jaw Angulation | Vario, straight, up &
down, left & right | Straight, up & down, left
& right | Straight, up & down, left
& right | Vario & various |
| Optional Latch | Yes | Latch or no-latch | No Latch | Latch or no-latch |
| Designated
clips | YASARGIL Titanium
Clips only
(Standard/Mini) | YASARGIL Titanium
or Phynox clips
(Standard/Mini) | YASARGIL Titanium
or Phynox clips
(Standard/Mini) | YASARGIL Titanium
Clips only
(Standard/Mini) |
| Non-Sterile | Yes | Same | Same | Same |
| Clip
Designation
Feature | Yes (POM-C or
Propylux Plug & Laser
marking on spring) | Same | Same | POM-C |
| Coating | Yes | No coating | No coating | No coating |
TESTING
There is no change to the base design, functionality or intended use of the clip appliers with added coating. Bench testing results demonstrate that the Aesculap Slim Clip Applier is substantially equivalent to the Aesculap Slim Clip Appliers currently on the market. The bench testing of clip appliers demonstrates that the Aesculap Slim Clip Applier forceps perform as intended and are as safe, effective, and perform as well as the predicate devices.
5
| Performance Test Completed | Test purpose | Results | Conclusion |
|---|---|---|---|
| Verification test for clip | |||
| opening | To verify the minimum opening | ||
| width of aneurysm clips meets the | |||
| requirement. | Pass | The Aesculap Slim | |
| Clip Appliers meet | |||
| the test acceptance | |||
| criteria. |
STERILIZATION: The Aesculap Slim Clip Applier forceps will continue to be provided nonsterile similar to the predicate devices. They are intended to be sterilized prior to use.
BIOCOMPATIBILITY: Testing confirmed that the Aesculap Slim Clip Appliers with added coating are biocompatible.
| Test | Summary | Conclusion |
|---|---|---|
| Cytotoxicity | Test articles were extracted for 24 hours per ISO 10993-5. All test | |
| articles exhibited a reactivity grade of 0. Positive and negative | ||
| controls behaved as anticipated. | Non-cytotoxic | |
| Sensitization | The test article extracts showed no evidence of causing delayed | |
| dermal contact sensitization in the guinea pig. The test article was | ||
| not considered a sensitizer in the guinea pig maximization test. | Non-sensitive | |
| Pyrogenicity | The purpose of this assessment is to determine if a test article | |
| extract induces a pyrogenic response following intravenous | ||
| injection in rabbits (temperature rise below 0.5 °C | ||
| indicates the absence of pyrogens). Based on the assessment | ||
| per ISO 10993-11, the materials are non-pyrogenic. | Non-pyrogenic | |
| Irritation | All animals appeared normal throughout the study. The test article | |
| met the requirements of the test since the difference between each | ||
| test article extract overall mean score and corresponding control | ||
| extract overall mean score was 0.0 for both the SC and SO test | ||
| article extracts. | Normal | |
| Systemic Toxicity | There was no mortality or evidence of systemic toxicity from the | |
| extracts injected into mice. Each test article extract met the | ||
| requirements of the study. | Non-Toxic | |
| Hemolysis | The test article extract was tested in vitro. The hemolytic index for | |
| the test article extract was 0.0% and the test article extract was | ||
| considered non-hemolytic. | Non-Hemolytic |
CONCLUSION
Aesculap Slim Clip Applier forceps presented in this submission are substantially equivalent in design, intended use, and performance to the predicate and reference devices. The added coating does not raise new questions of safety and effectiveness.