(29 days)
No
The device description and performance studies focus on mechanical function and substantial equivalence to a predicate device, with no mention of AI or ML.
Yes
The device, Aesculap Slim Clip Applier forceps, is used to open, close, and apply aneurysm clips. This action directly facilitates a medical procedure to treat aneurysms, making it a therapeutic device.
No
The Aesculap Slim Clip Applier forceps are described as instruments for applying aneurysm clips during surgery, not for diagnosing conditions.
No
The device description clearly states it is a physical instrument made of stainless steel (forceps) and includes details about its material, dimensions, and physical features. There is no mention of software as a component of the device itself.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Aesculap Slim Clip Applier forceps are surgical instruments used during a surgical procedure to apply aneurysm clips directly to an aneurysm within the body. They are not used to test or analyze biological samples.
- Intended Use: The intended use clearly states "used for opening, closing, and applying Aesculap YASARGIL aneurysm clips," which is a surgical action, not an in vitro diagnostic test.
The information provided about the device's materials, design, and performance testing all relate to its function as a surgical tool, not an IVD.
N/A
Intended Use / Indications for Use
The Aesculap Slim Clip Applier forceps are used for opening, closing, and applying Aesculap YASARGIL aneurysm clips.
Product codes (comma separated list FDA assigned to the subject device)
HCI
Device Description
The Aesculap Slim Clip Applier forceps are manufactured from stainless steel (body & jaw). The appliers are available in lengths ranging from 50 mm to 110 mm. In addition to the straight jaw configuration, the Clip Appliers are available with jaws angled up & down, left & right.
Each Clip Applier is individually laser marked with the type of clip designated for use. In addition, identification plugs to easily identify each clip designation are placed in the handles.
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)
Study Type: Bench Testing
Key Results: Bench testing results demonstrate that the Aesculap Slim Clip Applier forceps are substantially equivalent when compared to the Aesculap Clip Appliers currently on the market. Bench testing was performed to demonstrate that the Aesculap Slim Clip Applier forceps perform as intended and are safe, as effective, and perform as well as the predicate device.
Performance Test completed: Benchmark Functional Test
- Methodology:
- (1) Meet required interface and opening width of the aneurysm clip.
- (2) Successful release of designated aneurysm clip in the craniotomy.
- Results: Pass
- Conclusions: The devices interfaced successfully with the aneurysm clips while providing the correct opening width. In addition the devices successfully released the aneurysm clips within the craniotomy.
Performance Test completed: Predicate/Subject Device Comparison Test
- Methodology: Comparison between predicate and subject device ensuring:
- (1) Required interface and opening width of designated aneurysm clip.
- (2) Successful release of aneurysm clip in the craniotomy.
- Results: Pass
- Conclusions: The performance testing demonstrated that the subject devices are substantially equivalent to the predicate devices.
Performance Test completed: Usability Test
- Methodology:
- (1) Ensuring identification of designated clip type for the specific clip applier.
- (2) Legibility of additional Clip Applier identification features, i.e. company name, article number, and UDI information.
- (3) Ensuring visualization of surgical site.
- (4) Ability to grasp, hold, and apply YASARGIL Aneurysm Clip
- Results: Pass
- Conclusions: The usability test demonstrated that the subject devices were properly identified and met the usability requirements.
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.
K131500 (including K043041, K003519, K002871, K984109, K983758, K970050, K940970, K922272, K913765, K833651, K833650 and K772200)
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
§ 882.4175 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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
November 10, 2017
Aesculap, Inc. Paul Amudala Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K173271
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: October 11, 2017 Received: October 12, 2017
Dear Mr. 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. 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 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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,
Carlos L. Pena -S
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name Aesculap Slim Clip Applier
Indications for Use (Describe)
The Aesculap Slim Clip Applier forceps are used for opening, closing, and applying Aesculap Y ASARGIL aneurysm clips.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Page 1 of 3
510(K) SUMMARY - K173271
| | Aesculap Slim Clip Applier
Nov 9, 2017 |
|--------------------|--------------------------------------------------------------------------------------------------------------------|
| COMPANY: | Aesculap®, Inc.
3773 Corporate Parkway
Center Valley, PA 18034
Establishment Registration Number: 2916714 |
| CONTACT: | Paul Amudala
610-984-9303 (phone)
610-791-6882 (fax)
paul.amudala@aesculap.com |
| TRADE NAME: | Aesculap Slim Clip Applier |
| COMMON NAME: | Aneurysm Clip Applier |
| REGULATION NUMBER: | 882.4175 – Applier, Aneurysm Clip |
| PRODUCT CODE: | HCI |
| REVIEW PANEL: | Neurology |
SUBSTANTIAL EQUIVALENCE
Aesculap, Inc. believes that the Aesculap Slim Clip Applier forceps are substantially equivalent to Clip Appliers cleared in Primary Predicate K131500 (including K043041, K003519, K002871, K984109, K983758, K970050, K940970, K922272, K913765, K833651, K833650 and K772200).
DEVICE DESCRIPTION
The Aesculap Slim Clip Applier forceps are manufactured from stainless steel (body & jaw). The appliers are available in lengths ranging from 50 mm to 110 mm. In addition to the straight jaw configuration, the Clip Appliers are available with jaws angled up & down, left & right.
Each Clip Applier is individually laser marked with the type of clip designated for use. In addition, identification plugs to easily identify each clip designation are placed in the handles.
INDICATIONS FOR USE
The Aesculap Slim Clip Applier forceps are used for opening, closing, and applying Aesculap YASARGIL aneurysm clips.
4
TECHNOLOGICAL CHARACTERISTICS (Compared to the Primary Predicate)
The Aesculap Slim Clip Applier forceps are substantially equivalent to the predicate Aesculap YASARGIL Aneurysm Clip Applying forceps. The intended use, fundamental scientific principles, and base materials of the Clip Appliers (body and jaw) remain unchanged since last clearance. The Aesculap Slim Clip Applier forceps have minor geometrical changes and an optional new identification plug material change but functions the same as the predicate. The Device is provided.
| Principle Device | Primary Predicate device K131500 | |
|---|---|---|
| (including K043041, K003519, | ||
| K002871, K984109, K983758, | ||
| K970050, K940970, K922272, | ||
| K913765, K833652, K833651, | ||
| K833650 and K772200) YASARGIL | ||
| Aneurysm Clips and Clip Appliers | ||
| (Clip Appliers only) | ||
| Indications | The Aesculap Slim Clip | |
| Applier forceps are used | ||
| for opening, closing, and | ||
| applying Aesculap | ||
| YASARGIL aneurysm | ||
| clips. | The YASARGIL Aneurysm Clips | |
| are intended for occlusion of cerebral | ||
| aneurysms in either a temporary or | ||
| permanent manner. They are applied | ||
| with Aesculap Clip Appliers, which | ||
| contain titanium alloy or phynox | ||
| jaws- | ||
| Clip Applier: | ||
| Body Material (Jaw & | Stainless Steel | Titanium Alloy (Ti6AI6V) or |
| Body) | Stainless Steel | |
| Length | 50 mm to 110 mm | 50 mm, 70 mm, 90 mm, and 110 mm |
| Jaw Angulation | Straight, up & down, left & | Straight, angled, bayonet |
| right | ||
| Optional Latch | No | Yes |
| Non-Sterile | Yes | Yes |
| Clip Designation Feature | Yes | Yes |
TESTING
All required testing per "Draft Guidance for the Preparation of Premarket Notifications (510(k)s)" was completed for the Aesculap Slim Clip Applier forceps. Bench testing results demonstrate that the Aesculap Slim Clip Applier forceps are substantially equivalent when compared to the Aesculap Clip Appliers currently on the market. Bench testing was performed to demonstrate that the Aesculap Slim Clip Applier forceps perform as intended and are safe, as effective, and perform as well as the predicate device.
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| Page | 3 | of 3 |
|---|---|---|
| ------ | --- | ------ |
| Performance Test completed | Methodology | Results | Conclusions |
|---|---|---|---|
| Benchmark Functional Test | (1) Meet required interface and opening width of the aneurysm clip. | ||
| (2) Successful release of designated aneurysm clip in the craniotomy. | Pass | The devices interfaced successfully with the aneurysm clips while providing the correct opening width. In addition the devices successfully released the aneurysm clips within the craniotomy. | |
| Predicate/Subject Device Comparison Test | Comparison between predicate and subject device ensuring: | ||
| (1) Required interface and opening width of designated aneurysm clip. | |||
| (2) Successful release of aneurysm clip in the craniotomy. | Pass | The performance testing demonstrated that the subject devices are substantially equivalent to the predicate devices. | |
| Usability Test | (1) Ensuring identification of designated clip type for the specific clip applier. | ||
| (2) Legibility of additional Clip Applier identification features, i.e. company name, article number, and UDI information. | |||
| (3) Ensuring visualization of surgical site. | |||
| (4) Ability to grasp, hold, and apply YASARGIL Aneurysm Clip | Pass | The usability test demonstrated that the subject devices were properly identified and met the usability requirements. |
Sterilization: The Aesculap Slim Clip Applier forceps will continue to be provided non-sterile similar to the predicate device. They are intended to be sterilized prior to use.
Biocompatibility: There is no change to the patient contacting material of the Aesculap Slim Clip Applier forceps since they are manufactured from the same Stainless Steel as the predicate device.
CONCLUSION
Aesculap believes that the Aesculap Slim Clip Applier forceps presented in this submission are substantially equivalent in design, materials, intended use, and perform as safe and effective as Aesculap's currently marketed devices.