The Fine Surgical Gomco Circumcision Clamp is a disposable medical device that is constructed of chrome plated brass. The device will be sold non sterile for further processing (ie. Packaging and sterilization) by the final distributor. We do not intend to sell these devices directly to the end user.

AI/ML Overview

Here's an analysis of the provided text regarding the Fine Surgical Circumcision Clamp's acceptance criteria and the study (or lack thereof) to prove it:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit)	Reported Device Performance (Implicit from Substantial Equivalence Claim)
Intended Use: Used in medical procedure to compress the foreskin of the penis during circumcision of a male infant or child.	Meets intended use, identical to predicate device, with additional size for "child."
Material: Chrome plated brass.	Chrome plated brass.
Disposable: Not intended for re-use.	Disposable.
Non-sterile: Sold non-sterile for further processing (packaging and sterilization) by final distributor.	Sold non-sterile for further processing.
Safety and Effectiveness: Implied to be safe and effective for its intended use, based on predicate.	Declared safe and effective based on substantial equivalence to predicate device.
Available Sizes (expanded): Extra Small: 1.1 cm, Newborn: 1.3 cm, Infant: 1.45 cm, Child: 1.6 cm.	Device is available in these sizes, including a new "Child" size.

2. Sample size used for the test set and the data provenance:

Sample Size: Not applicable. No test set was used because no non-clinical or clinical tests were performed.
Data Provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No ground truth was established from experts for a test set, as no tests were performed.

4. Adjudication method for the test set:

Not applicable. No test set was used.

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 device is a manual surgical instrument, not an AI-powered diagnostic or assistive technology. No MRMC study was performed.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a manual surgical instrument, not an algorithm.

7. The type of ground truth used:

Implicit Ground Truth: The ground truth for the acceptability of the Fine Surgical Circumcision Clamp is based on its substantial equivalence to a legally marketed predicate device (Centurion® CirClamp™). The predicate device's prior marketing and presumed safety/effectiveness serve as the "ground truth" for the new device's acceptance.

8. The sample size for the training set:

Not applicable. This device is a manual surgical instrument and does not involve AI or machine learning, thus no training set was used.

9. How the ground truth for the training set was established:

Not applicable. There was no training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

Based on the provided 510(k) summary, "no clinical testing was performed" and "non Clinical testing was not performed."

The "study" that proves the device meets the acceptance criteria is explicitly stated as a comparison to a predicate device (the Centurion® CirClamp™). The submitter, Fine Surgical Instruments, Inc., argues that their device is "identical in materials, design, and intended use" to the predicate, with two minor differences:

It will be offered non-sterile for further processing.
A larger size will be available (1.6 cm, designated "Child").

The FDA's finding of substantial equivalence allows the device to be marketed. This means that the FDA determined the new device is as safe and effective as a legally marketed device that was on the market prior to May 28, 1976 (or a reclassified device that doesn't need premarket approval). The acceptance criteria are "met" by demonstrating that the new device is essentially the same as an already accepted device.

Summary

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510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is:

Submitter's Identification: 1.

Fine Surgical Instruments, Inc. 741Peninsula Blvd. Hempstead, NY 11550 Tel: 516-292-7400 Fax: 516-292-7484

Date Summary Prepared: January 9, 2004

2. Name of the Device:

Proprietary: Fine Surgical Circumcision Clamp a.
Common Name: Gomco Style Circumcision Clamp b.
Classification Name: Circumcision Clamp C.
d. Device Class: 21 CFR 884.4530, Class II
Classification Panel: Obstetrical and Gynecological Panel e.
Product Code: HFX f.

3. Predicate Device Information:

The Fine Surgical Circumcision Clamp is identical in materials, design, and intended use to the Centurion® CirClamp™ circumcision clamps marketed by Tri-State Medical Corp. (K890897). The Fine Surgical clamp differs from the predicate in that it will be offered non-sterile for further processing and a larger size will be available.

4. Device Description:

5. Intended Use:

The Fine Surgical Circumcision Clamp is intended to be used in a medical procedure to compress the foreskin of the penis during circumcision of a male infant or child.

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	Fine Surgical GomcoCircumcision Clamp	Centurion® CirClamp™
Intended Use	Infant and Childcircumcision	Infant Circumcision
Sizes Available	Extra Small: 1.1 cmNewborn: 1.3 cmInfant: 1.45 cmChild: 1.6 cm	Extra Small: 1.1 cmNewborn: 1.3 cmInfant: 1.45 cm
Materials	Chrome-Plated Brass	Chrome-Plated Brass
Re-Use	No, disposable	No, disposable

Comparison to Predicate Devices: 6.

Discussion of Non-Clinical Tests Performed for Determination 7. of Substantial Equivalence are as follows:

Non-Sterile

Non Clinical testing was not performed

Discussion of Clinical Tests Performed: 8.

Clinical testing was not performed

9 Conclusions:

Sterility

The Fine Surgical Gomco-Style Circumcision Clamp is safe and effective for if's intended use.

Sterile

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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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized design featuring three overlapping shapes that resemble human figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 9 2004

Fine Surgical Instruments, Inc. c/o Ms. Carolann Kotula Official Correspondent mdi Consultants, Inc. 55 Northern Blvd. GREAT NECK NY 11021

Re: K040052

Trade/Device Name: Fine Surgical Circumcision Clamp Regulation Number: 21 CFR §884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulatory Class: II Product Code: 85 HFX Dated: January 9, 2004 Received: January 12, 2004

Dear Ms. Kotula:

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 requircments as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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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. Bryden

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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ATTACHMENT 3

Page __ 1 __ of __ 1

510(k) Number (if known): _ 长0400 5 2

Device Name: Fine Surgical Instruments Gomco-Style Circumcision Clamp

Indications For Use:

A Circumcision Clamp is an instrument used in a procedure to compress the foreskin of the penis during circumcision of male infant or child.

Prescription Use _ × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices,
K040052

Regulation Number and Section

§ 884.4530 Obstetric-gynecologic specialized manual instrument.

(a)
Identification. An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:(1) An amniotome is an instrument used to rupture the fetal membranes.
(2) A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant.
(3) An umbilical clamp is an instrument used to compress the umbilical cord.
(4) A uterine curette is an instrument used to scrape and remove material from the uterus.
(5) A fixed-size cervical dilator is any of a series of bougies of various sizes used to dilate the cervical os by stretching the cervix.
(6) A uterine elevator is an instrument inserted into the uterus used to lift and manipulate the uterus.
(7) A gynecological surgical forceps is an instrument with two blades and handles used to pull, grasp, or compress during gynecological examination.
(8) A cervical cone knife is a cutting instrument used to excise and remove tissue from the cervix.
(9) A gynecological cerclage needle is a looplike instrument used to suture the cervix.
(10) A hook-type contraceptive intrauterine device (IUD) remover is an instrument used to remove an IUD from the uterus.
(11) A gynecological fibroid screw is an instrument used to hold onto a fibroid.
(12) A uterine sound is an instrument used to determine the depth of the uterus by inserting it into the uterine cavity.
(13) A cytological cervical spatula is a blunt instrument used to scrape and remove cytological material from the surface of the cervix or vagina.
(14) A gynecological biopsy forceps is an instrument with two blades and handles used for gynecological biopsy procedures.
(15) A uterine tenaculum is a hooklike instrument used to seize and hold the cervix or fundus.
(16) An internal pelvimeter is an instrument used within the vagina to measure the diameter and capacity of the pelvis.
(17) A nonmetal vaginal speculum is a nonmetal instrument used to expose the interior of the vagina.
(18) A fiberoptic nonmetal vaginal speculum is a nonmetal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina.
(b)
Classification. (1) Class II (special controls). The device, when it is an umbilical clamp with or without a cutter, a uterine tenaculum which is sterile and does not use suction and is intended for single use, a nonmetal vaginal speculum, or a fiberoptic nonmetal vaginal speculum, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.(2) Class I for the amniotome, uterine curette, cervical dilator (fixed-size bougies), cerclage needle, IUD remover, uterine sound, and gynecological biopsy forceps. 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.