(24 days)
The Endoscopic Clip Appliers with clip magazine are intended for use in endoscopic surgery for ligating, marking vessels and tubular structures wherever a ligating clip is used/indicated.
Aesculap's Endoscopic Clip Appliers consists of two types of clip appliers (multifire (manual) or pneumatic (used CO2 cartridge). The clip appliers are reusable instruments that have either a 5 or 10 mm diameter and range in length from 260mm to 370mm. They are designed for use with a disposable clip magazine which attaches to the shaft of the clip applier. The new clip magazine cartridge hold 8 titanium clips which can be applied one at a time. The instrument handle has a control lever for supplying the clips and a separate control lever for closing the clips. The design enables the surgeon to apply several clips without the need for withdrawing and reinserting the clip applier each time.
The provided text does not contain detailed information regarding specific acceptance criteria, a formal study proving device performance against such criteria, or data related to AI/algorithm performance. The document is a 510(k) summary for an Endoscopic Clip Applier line extension, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results.
Here's a breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document explicitly states: "No applicable performance standards have been promulgated under Section 514 of the Food, Drug, and Cosmetic Act for these devices." Therefore, there is no table of acceptance criteria or reported device performance against such criteria in the provided text. The submission relies on demonstrating substantial equivalence based on similar technological characteristics and materials to a predicate device (Aesculap Endoscopic Clip Appliers, K962493).
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable. The document does not describe a performance study with a test set. The substantial equivalence argument is based on design and material similarities.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
Not applicable. No test set was described to establish ground truth.
4. Adjudication Method for the Test Set:
Not applicable. No test set was described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. The document does not describe a comparative effectiveness study involving human readers or AI.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:
Not applicable. This device is a mechanical medical instrument, not an AI algorithm.
7. Type of Ground Truth Used:
Not applicable. Ground truth is not relevant in the context of this 510(k) submission, which focuses on substantial equivalence of a physical device.
8. Sample Size for the Training Set:
Not applicable. This device is a mechanical medical instrument, not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. This device is a mechanical medical instrument, not an AI algorithm.
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Endoscopic Clip Appliers Line Extension
K081031 page 1/2
Page 1 of 2
510(k) SUMMARY (as required by 21 CFR 807.92) B.
Endoscopic Clip Applier Line Extension April 11, 2007
MAY - 5 2008
| COMPANY: | Aesculap®, Inc.3773 Corporate ParkwayCenter Valley, PA 18034Establishment Registration Number: 2916714 |
|---|---|
| ---------- | -------------------------------------------------------------------------------------------------------------------- |
- CONTACT: Lisa M. Bovle 800-258-1946 (phone) 610-791-6882 (fax) lisa.boyle@aesculap.com (email)
COMMON NAME: Endoscopic Clip System
CLASSIFICATION NAME: Clips, Implantable
REGULATION NUMBER: 878.4300
PRODUCT CODE: FZP
SUBSTANTIAL EQUIVALENCE
Aesculap®, Inc. believes that the Endoscopic Clip Applier modifications and the addition of the clip maqazine are substantially equivalent to the existing components of the Aesculap Endoscopic Clip Appliers (K962493).
DEVICE DESCRIPTION
Aesculap's Endoscopic Clip Appliers consists of two types of clip appliers (multifire (manual) or pneumatic (used CO2 cartridge). The clip appliers are reusable instruments that have either a 5 or 10 mm diameter and range in length from 260mm to 370mm. They are designed for use with a disposable clip magazine which attaches to the shaft of the clip applier. The new clip magazine cartridge hold 8 titanium clips which can be applied one at a time. The instrument handle has a control lever for supplying the clips and a separate control lever for closing the clips. The design enables the surgeon to apply several clips without the need for withdrawing and reinserting the clip applier each time.
INDICATIONS FOR USE
The Endoscopic Clip Appliers with clip magazine are intended for use in endoscopic surgery for ligating, marking vessels and tubular structures in wherever a ligating clip is used/indicated.
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TECHNOLOGICAL CHARACTERISTICS(compared to Predicate(s)}
The modified clip appliers and the new clip magazine of the Endoscopic Clip Applier System are offered in similar in shapes and sizes as the predicate device. All the components are manufactured from Stainless Steel / Titanium, which is the same material as the predicate devices.
PERFORMANCE DATA
No applicable performance standards have been promulgated under Section 514 of the Food, Drug, and Cosmetic Act for these devices.
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black against a white background. The seal is a symbol of the department's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 5 2008
Aesculap, Inc. % Ms. Lisa M. Boyle Senior Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K081031
Trade/Device Name: Endoscopic Clip Appliers with Clip Magazine Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: FZP, GDO Dated: April 10, 2008 Received: April 11, 2008
Dear Ms. Boyle:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Lisa M. Boyle
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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A. INDICATIONS FOR USE STATEMENT
510(k) Number: K061031
Device Name: Endoscopic Clip Appliers with Clip Magazine
Indications for Use:
The Endoscopic Clip Appliers with clip magazine are intended for use in endoscopic surgery for ligating, marking vessels and tubular structures wherever a ligating clip is used/indicated.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
R. Thang
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K081031
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.