(90 days)
Aesculap's Reposable Instrument System is designed to cut, dissect, manipulate and/or cauterize various tissue during endoscopic/laparoscopic, general, vascular, gynecological, and thoracic surgical procedures.
Aesculap's Reposable Instrument System is comprised of non-sterile, reusable handles which are capable of monopolar electrocautery, via a underside connection terminal, reusable jaw inserts which come in different sizes and one single use endoscopic scissors. The jaw inserts include the blades, shaft and locking nut. The reusable scissors insert is supplied non-sterile, and the single use scissors insert is supplied sterile. The reusable and single use jaw inserts are intended to be use with either the non-ratcheted or ratcheted handle.
The provided text is a 510(k) summary for a medical device (K014207: Reposable Instrument System). It explicitly states: "No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. The Reposable Instrument System, however, conform to the following electromedical standard: IEC/EN 60601-2-2 and IEC/EN 60601-2-18."
This means there are no specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy targets) for this device in the traditional sense, as it is a surgical instrument system, not an AI or diagnostic device. The "performance data" section indicates conformance to electromedical standards, which are about electrical safety and basic functionality for electrosurgical devices, rather than clinical performance metrics.
Therefore, many of the requested points are not applicable to this particular 510(k) submission.
Here's an attempt to answer based on the provided information, addressing what is present and noting what is not:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|
| Conformance to IEC/EN 60601-2-2 (Electrosurgical Equipment Safety) | The Reposable Instrument System "conform to the following electromedical standard: IEC/EN 60601-2-2". |
| Conformance to IEC/EN 60601-2-18 (Endoscopic Equipment Safety) | The Reposable Instrument System "conform to the following electromedical standard: IEC/EN 60601-2-18". |
| Substantial Equivalence to Predicate Devices (K980758, K970826, K926203) | The Reposable Instrument System is deemed "substantially equivalent in their intended use, material composition, labeling, design and basic operating principles" to the listed predicate devices. This implies it performs similarly to devices already on the market and accepted for their intended use. Specific performance metrics are not given, as the equivalence is based on design and function. |
2. Sample size used for the test set and the data provenance
- Not Applicable. This is a surgical instrument device, not a diagnostic or AI device that relies on a test set of data (e.g., images, patient records). The "testing" refers to conformance to engineering standards and comparison to predicate devices, not studies with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. See point 2. Ground truth, in the context of diagnostic/AI devices, is not relevant here.
4. Adjudication method for the test set
- Not Applicable. See point 2.
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 is a surgical instrument, not an AI device or a diagnostic aid for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a surgical instrument.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. See point 2. The basis for approval is conformance to electromedical standards and substantial equivalence, not a "ground truth" derived from patient data.
8. The sample size for the training set
- Not Applicable. This is a surgical instrument, not an AI device that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
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K014207
Page 1 of 1
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS in Accordance with SMDA of 1990
REPOSABLE INSTRUMENT SYSTEM
December 19, 2001
| COMPANY: | Aesculap®, Inc.3773 Corporate ParkwayCenter Valley, PA 18034 |
|---|---|
| CONTACT: | Lisa M. Millington, Regulatory Associate800-258-1946 (phone) x5072610-791-6882 (fax)lisa.millington@aesculap.com (email) |
| TRADE NAME: | Reposable Instrument System |
| COMMON NAME: | Disposable / Reusable Instrument System |
| DEVICE CLASS: | Class II |
| PRODUCT CODE: | GEI |
| CLASSIFICATION: | 878.4800Device, Electrosurgical, Cutting & Coagulation & Accessories |
| REVIEW PANEL: | General & Plastic Surgery |
INTENDED USE
Aesculap's Reposable Instrument System is designed to cut, dissect, manipulate and/or cauterize various tissue during endoscopic/laparoscopic, general, vascular, gynecological, and thoracic surgical procedures.
DEVICE DESCRIPTION
Aesculap's Reposable Instrument System is comprised of non-sterile, reusable handles which are capable of monopolar electrocautery, via a underside connection terminal, reusable jaw inserts which come in different sizes and one single use endoscopic scissors. The jaw inserts include the blades, shaft and locking nut. The reusable scissors insert is supplied non-sterile, and the single use scissors insert is supplied sterile. The reusable and single use jaw inserts are intended to be use with either the non-ratcheted or ratcheted handle.
PERFORMANCE DATA
No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. The Reposable Instrument System, however, conform to the following electromedical standard: IEC/EN 60601-2-2 and IEC/EN 60601-2-18.
SUBSTANTIAL EQUIVALENCE
The Reposable Instrument System are substantially equivalent in their intended use, material composition, labeling, design and basic operating principles to the following predicate devices:
- Microline: .
- Weck's Endoscopic Instrument System (Disposable/Reusable) (K926203)
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ·
MAR 2 1 2002
Ms. Lisa M. Millington Regulatory Associate Aesculap, Inc. 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K014207
Trade/Device Name: Reposable Instrument System Regulation Number: 878.4400 Regulation Name: Electrosurgical, Cutting and Coagulation Devices and Accessories Regulatory Class: II
Product Code: GEI Dated: December 20, 2001 Received: December 21, 2001
Dear Ms. Millington:
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.
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 (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.
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Page 2 - Ms. Lisa M. Millington
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Premarket Notification
Reposable Instrument System
Page 1 of 1
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
510(k) Number (if known):
Device Name: Reposable Instrument System
Indication for Use:
Assoulap's Reposable Instrument System is designed to cut, dissect, manipulate and/or cauterize various tissue during endoscopic general, vascular, gynecological, and thoracic surgical procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | / | or Over-the-Counter Use | |
|---|---|---|---|
| ------------------ | ----------------------------------------------------- | ------------------------- | --------------------------------------------------- |
(per 21 CFR 801.109)
(Optional Format 3-10-98)
Miriam C. Provost
(Division of General, Restorative Division of Neurological Devices
510(k) Number K014207
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.