(90 days)
Not Found
No
The summary describes a mechanical and electrical surgical instrument system with no mention of AI or ML capabilities.
No.
The device is described as a surgical instrument system designed to cut, dissect, manipulate, and cauterize tissue during surgical procedures. It is not intended for the treatment, prevention, or diagnosis of disease, which are characteristics of a therapeutic device.
No
The device is described as a surgical instrument system designed to cut, dissect, manipulate, and/or cauterize tissue during surgical procedures, not to diagnose medical conditions.
No
The device description explicitly details physical hardware components including handles, jaw inserts, and scissors, and mentions electrocautery capabilities, indicating it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is designed to "cut, dissect, manipulate and/or cauterize various tissue during endoscopic/laparoscopic, general, vascular, gynecological, and thoracic surgical procedures." This describes a device used on the patient during surgery, not a device used to test samples from the patient in a laboratory setting.
- Device Description: The description details surgical instruments like handles, jaw inserts, and scissors. These are tools for performing surgical procedures.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), reagents, or laboratory procedures, which are hallmarks of IVD devices.
Therefore, the Aesculap's Reposable Instrument System is a surgical instrument, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
GEI
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.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 Parkway
Center Valley, PA 18034 |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Lisa M. Millington, Regulatory Associate
800-258-1946 (phone) x5072
610-791-6882 (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: | 878.4800
Device, 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)
1
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.
2
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
3
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