(357 days)
Not Found
No
The description focuses on mechanical and electrical components for surgical manipulation and electrocautery, with no mention of AI or ML capabilities.
Yes
The device is designed to manipulate, dissect, and coagulate tissue, which are actions performed as part of a medical treatment, thereby making it a therapeutic device.
No
Explanation: The device is designed to manipulate, dissect, and coagulate tissue during laparoscopic surgery, which are therapeutic and manipulative functions, not diagnostic ones. There is no mention of image processing, AI, or specific performance metrics related to diagnostic capabilities.
No
The device description clearly outlines physical components like a carbon fiber handle, stainless steel pull rod and jaw, and insulation material. It also describes the device's function as manipulating tissue and providing electrocautery, which are hardware-based actions.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "manipulate tissue, organs, or bowel during laparoscopic surgery" and "provide monopolar electrocautery capability to dissect and coagulate tissue." This describes a surgical instrument used in vivo (within the body) for direct surgical procedures.
- Device Description: The description details a surgical instrument with a handle, pull rod, jaw, and insulation, designed for physical manipulation and electrocautery.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnostic, monitoring, or compatibility purposes. This device does not perform any such function.
The device is clearly a surgical instrument used for direct intervention on a patient's body during surgery, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The devices are designed to manipulate tissue, organs, or bowel during laparoscopic surgery. The secondary function is to provide monopolar electrocautery capability to dissect and coagulate tissue.
Product codes (comma separated list FDA assigned to the subject device)
85 HET
Device Description
These devices represent a family of monopolar laparoscopic instruments that consist of:
- Carbon Fiber Handle (ratcheted and non-ratcheted)
- Stainless Steel Pull Rod attached to a stainless steel jaw
- Insulation material composed of PPSU (PolyPhenylSulfone).
There are various configurations of the jaw (graspers, cutters, and dissectors) to meet the needs of the surgical procedure. The instruments have the capability for monopolar electrocautery to allow for the cutting and coagulation of soft tissue.
These reusable instruments are sold non-sterile. The instruments are packaged in a labeled plastic bag that contains the Directions for Use (DFU).
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)
The patient contact materials are commonly used in medical devices and have a long history of biocompatibility. The stainless steel 420 is compliant with DIN 17442 standard for Corrosion Resistant Steels for Medical Equipment. The subject devices can withstand 7500 Volts and are compliant with the standard DIN 53483 Dielectric Constant.
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.
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
§ 884.1720 Gynecologic laparoscope and accessories.
(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.
0
K021237 page 1 of 2
510 (k) Summary [as required by 21 CFR 807.92]
APR 1 0 2003
Date Prepared [21 CFR 807.92(a)(1)]
April 18, 2002
Submitter's Information [21 CFR 807.92(a)(1)]
Joseph M. Azary C/o CooperSurgical Inc. P.O. Box 2156 Huntington, CT. 06484
Azary Technologies has received authorization to submit this 510(k) on behalf of the sponsor CooperSurgical Inc., 95 Corporate Drive, Trumbull, CT 06611.
Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
The device trade names are: CooperSurgical Laparoscopic Instruments
Common Name: Monopolar Laparoscopic Instruments, Laparoscopic Grasper, Laparoscopic Cutter, Laparoscopic Dissector, Electrosurgical instruments, Endoscopic Instruments.
Predicate Device [21 CFR 807.92(a)(3)]
- Primus Insulated Forceps Marlow Surgical Technology K932832 .
- Family of Primus Forceps; Graspers and Dissectors Marlow Surgical Technology K944563 .
The subject devices have the same indications for use as the predicates, have stainless steel jaws, are both sold non-sterile, and have monopolar electrocautery capability. The main differences are; change in materials for the handle (carbon fiber versus stainless steel), electrocautery adaptor position has changed from 90 degrees to 45 degrees, and the cleaning method (cleaning port versus disassembly).
Description of the Device [21 CFR 807.92(a)(4)]
These devices represent a family of monopolar laparoscopic instruments that consist of:
- Carbon Fiber Handle (ratcheted and non-ratcheted) ●
- Stainless Steel Pull Rod attached to a stainless steel jaw
- Insulation material composed of PPSU (PolyPhenylSulfone).
There are various configurations of the jaw (graspers, cutters, and dissectors) to meet the needs of the surgical procedure. The instruments have the capability for monopolar electrocautery to allow for the cutting and coagulation of soft tissue.
These reusable instruments are sold non-sterile. The instruments are packaged in a labeled plastic bag that contains the Directions for Use (DFU).
1
FDA 510(k) Premarket Notification CooperSurgical Laparoscopic Instruments
. K021327 page 202
Intended Use [21 CFR 807.92(a)(5)]
The devices are designed to manipulate tissue, organs, or bowel during laparoscopic surgery. The secondary function is to provide monopolar electrocautery capability to dissect and coagulate tissue.
Technological Characteristics [21 CFR 807.92(a)(6)]
CooperSurgical Inc. believes that the subject device is substantially equivalent to the predicate device.
Performance Data [21 CFR 807.92(b)(1)]
The patient contact materials are commonly used in medical devices and have a long history of biocompatibility. The stainless steel 420 is compliant with DIN 17442 standard for Corrosion Resistant Steels for Medical Equipment. The subject devices can withstand 7500 Volts and are compliant with the standard DIN 53483 Dielectric Constant.
Conclusion [21 CFR 807.92(b)(3)]
We believe the changes are minor and conclude that the subject devices are as safe and effective as the predicate devices.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected by a flowing line that resembles a ribbon or wave. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 0 2003
Mr. Thomas G. Williams Director, Quality Assurance and Regulatory Affairs CooperSurgical 95 Corporate Drive TRUMBULL CT 06611
Re: K021237
Trade/Device Name: SEE ATTACHMENT Regulation Number: 21 CFR 884.1720 Regulation Name: Gynecologic laparoscope and accessories Regulatory Class: II Product Code: 85 HET Dated: January 30, 2003
Received: February 3, 2003
Dear Mr. Williams:
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 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.
3
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 Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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) you may obtain. 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,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
4
K021237 Enclosure
Device List
Forcep Claw, 10mm, model M695 Grasper, Babcock, 5 mm, model MP759 Grasper, Cone Tip 33 cm, model M683 Scissors, Curved Metzenbaum Rotating, model M689 Models M681, MP756, M686, M682, and M694
5
5 10(k) Number (if known): K021237
Device Name: CooperSurgical Inc. Laparoscopic Instruments
Indications For Use: The devices are designed to manipulate tissue, organs, or bowel during laparoscopic surgery. The secondary function is to provide monopolar electrocautery capability to dissect and coagulate tissue.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use ___________
(Optional Format 1-2-96)
Nancy C Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number K021237
Page 4