(29 days)
80-1163, NU1060
Not Found
No
The description focuses on the physical components and function of a cord assembly for delivering electrical energy and irrigation fluid, with no mention of AI or ML capabilities.
No.
The device delivers electrical energy and irrigating solution to bipolar forceps; it does not directly treat a medical condition.
No.
The device is described as delivering electrical energy and irrigation solution, which are functions of a surgical tool rather than a diagnostic device.
No
The device description clearly indicates a physical product ("Disposable Irrigation Bipolar Cord Assembly") that delivers electrical energy and irrigating solution, involving hardware components like a cord, conduit, and reservoir.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device's function as delivering electrical energy and irrigating solution during surgical procedures using bipolar forceps. This is an in vivo application (within a living body), not an in vitro application (testing outside the body).
- Device Description: The description reinforces the intended use, focusing on its role in a surgical system for delivering energy and irrigation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
Therefore, the Disposable Irrigation Bipolar Cord Assembly is a surgical accessory used during procedures on a patient, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Disposable Irrigation Bipolar Cord Assembly is a single-use product sold sterile, and is intended for use with standard bipolar irrigating forceps, and the Codman & Shurtleff, Malis™ CMC - Bipolar System. This device is to be used to deliver electrical energy from a Malis™ CMC®-III (or equivalent) Generator to the bipolar forceps (handpiece), as well as, provide the system with an integrated delivery conduit, for carrying an irrigating solution from its collapsible reservoir to the forceps, via gravity feed.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Disposable Irrigation Bipolar Cord Assembly is a single-use product sold sterile. It is designed to deliver electrical energy from a Malis™ CMC®-III (or equivalent) Generator to bipolar irrigating forceps and to provide an integrated delivery conduit for irrigating solution from a collapsible reservoir to the forceps via gravity feed. Biological safety is assured through biocompatibility testing of irrigating lumen materials according to ISO Standard 10993-1. Sterilization safety is assured to a sterility assurance level (SAL) of 10-6, validated in accordance with AAMI / ISO 11137 and EN 552. Performance safety is assured via testing in accordance with IEC 601-1-2, IEC 601-2-2, and ANSI/AAMI HF 18.
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)
Performance safety will be assured via testing in accordance with, and in compliance with the requirements of the applicable sections of the following standards;
- IEC 601-1-2 (1988), Medical Electrical Equipment Part 1; General Requirements for the Safety.
- IEC 601-2-2 (1991), Medical Electrical Equipment Part 2; particular Requirements for the safety of High Frequency Surgical Equipment.
- ANSI/AAMI HF 18 (1993), American National Standard for Electrosurgical Devices
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.
80-1163, NU1060
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
§ 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
SUMMARY OF SAFETY AND EFFECTIVENESS
DISPOSABLE IRRIGATION BIPOLAR CORD ASSEMBLY for Malis™ System CMC®-II
The Disposable Irrigation Bipolar Cord Assembly is a single-use product sold sterile, and is intended for use with standard bipolar irrigating forceps, and the Codman & Shurtleff, Malis™ CMC -Bipolar System. This device is to be used to deliver electrical energy from a Malis ™ CMC -III (or equivalent) Generator to the bipolar irrigating forceps (handpiece), as well as, provide the system with an integrated delivery conduit, for carrying an irrigating solution from its collapsible reservoir to the forceps, via gravity feed.
Biological safety will be assured through the selection of irrigating lumen materials, which demonstrate appropriate levels of biocompatibility. The materials will be tested in accordance with ISO Standard 10993-1, Biological Evaluation of medical devices, part 1 (external communicating device, blood path indirect, contact duration category "A").
Sterilization safety will be assured to a sterility assurance level (SAL) of 10°. Sterility will be validated in accordance with, and in compliance with the requirements of the applicable sections of the following standards:
- 배 AAMI / ISO 11137 (current edition) Sterilization of health care productsrequirements for validation and routine control-radiation sterilization, and,
- 트 EN 552 (current edition) Sterilization of medical devices - Validation and routine control of sterilization by irradiation.
Performance safety will be assured via testing in accordance with, and in compliance with the requirements of the applicable sections of the following standards;
- 에 IEC 601-1-2 (1988), Medical Electrical Equipment Part 1; General Requirements for the Safety.
- 트 IEC 601-2-2 (1991), Medical Electrical Equipment Part 2; particular Requirements for the safety of High Frequency Surgical Equipment.
- 로 ANSI/AAMI HF 18 (1993), American National Standard for Electrosurgical Devices
The Disposable Irrigation Bipolar Cord Assembly is substantially equivalent in function and intended use to both the;
- 80-1163, Malis™ Integrated Irrigation Tubing and Bipolar Cord Set, and 트
- 마 NU1060, Irrigation / Bipolar Set, for Malis System CMC-II
TM Malis is a trademark of Leonard I. Malis, M.D.
® CMC is a registered trademark of Johnson & Johnson Professional, Inc.
Kirwan Surgical Products, Inc. Marshfield, MA 02050
1
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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, represented by curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 30 1999
Mr. Kevin P. Prario Regulatory Affairs Manager Kirwan Surgical Products, Inc. 180 Enterprise Drive P.O. Box 427 Marshfield, Massachusetts 02050
K992218 Re:
Trade Name: Disposable Irrigation Bipolar Cord Assembly Regulatory Class: II Product Code: GEI Dated: June 30, 1999 Received: July 1, 1999
Dear Mr. Prario:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Ouality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Mr. Kevin P. Prario
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
3
| 510(k) Number (if known): | K992218 |
|---|---|
| Date: | 6/30/99 |
Disposable Irrigation Bipolar Cord Assembly for Malis™ System CMC -II Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For use:
The Disposable Irrigation Bipolar Cord Assembly is a single-use product sold sterile, and is intended for use with standard bipolar irrigating forceps, and the Codman & Shurtleff, Malis™ CMC - Bipolar System. This device is to be used to deliver electrical energy from a Malis™ CMC®-III (or equivalent) Generator to the bipolar forceps (handpiece), as well as, provide the system with an integrated delivery conduit, for carrying an irrigating solution from its collapsible reservoir to the forceps, via gravity feed.
(Division Sian-Off of General Restorative Devices x 992218 510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
------------------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)