The Surgical Design 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(i.e. Packaging and Sterilization) by the Final Distributors. We do not intend to sell these devices to the end users.

AI/ML Overview

This document is a 510(k) summary for the Surgical Design Circumcision Clamp, which is a medical device. As such, it does not contain the typical information associated with studies proving a device meets acceptance criteria for an AI/ML or diagnostic device. The device in question is a physical surgical clamp, not a software or AI-driven system.

Based on the provided text, here's an analysis of the information related to acceptance criteria and "studies":

The document does not describe acceptance criteria in the typical quantitative or performance-based sense that would be expected for a diagnostic or AI device. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to a predicate device.

The "study" conducted to prove the device meets these criteria is a comparison to a predicate device, rather than a clinical trial or performance study.

Here's a breakdown based on your requested information, highlighting where the document's nature prevents providing the specific details you've asked for:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied by Substantial Equivalence to Predicate)	Reported Device Performance (Comparison to Predicate)
Material: Chrome-Plated Brass	Same as predicate
Design: Gomco-Style Circumcision Clamp	Same as predicate
Intended Use: Used in medical procedure to compress foreskin during circumcision of male infant or child	Intended for infant and child circumcision (Predicate: Infant Circumcision)
Re-use: No, disposable	Same as predicate
Sizes Available: (Specific sizes listed)	Extra Small: 1.1 CMNewborn: 1.3 CMInfant: 1.45 CMChild : 1.6 CM (Predicate did not have "Child" size)
Sterility: Non-Sterile (for further processing)	Non-Sterile (Predicate: Sterile)

Note: The acceptance criteria here are derived from the characteristics of the predicate device. The "performance" is simply confirming that the new device shares these characteristics or has acceptable differences.

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

Sample size for test set: Not applicable. No test set in the traditional sense was used. The evaluation centered on comparing the physical characteristics and intended use of the new device against an existing, legally marketed predicate device.
Data provenance: Not applicable. No "data" was collected from a test set of patients or images. The information comes from the physical specifications of the new device and the predicate device.

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

Not applicable. There was no "ground truth" to establish for a test set of diagnoses or observations, as this is a physical medical device (a clamp). The regulatory review for substantial equivalence is conducted by FDA personnel.

4. Adjudication method for the test set

Not applicable. No test set requiring adjudication was used. The determination of substantial equivalence is a regulatory decision made by the FDA.

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 not a diagnostic device or an AI-powered system. No MRMC study was conducted.

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

Not applicable. This is a physical, manual surgical instrument, not an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. For this type of device, the "ground truth" for regulatory approval is essentially the established safety and effectiveness of the legally marketed predicate device (Centurion® CirClamp™). The new device demonstrates substantial equivalence if it performs similarly and raises no new questions of safety or effectiveness.

8. The sample size for the training set

Not applicable. This is a physical device, not a machine learning model. There is no concept of a "training set."

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

Not applicable, as there is no training set.

In Summary:

This document is a 510(k) premarket notification for a physical medical device. The "study" described is a demonstration of substantial equivalence to a predicate device, which is a common regulatory pathway for many medical devices. It explicitly states:

"Non Clinical testing was not performed"
"Clinical testing was not performed"

The document aims to show that the Surgical Design Circumcision Clamp is "identical in material, design and intended use" to a previously cleared device, with minor differences (larger size available, non-sterile packaging) that do not raise new questions of safety or effectiveness. The FDA's letter confirms that they have reviewed the submission and determined the device is substantially equivalent to legally marketed predicate devices.

Summary

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Page 1 of 2

APR - 1 2005

EXIBIT#I

510(K) SUMMARY

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

Date Summary Prepared: December 21, 2004

X043533 The assigned 510(k) Number is_________________________________________________________________________________________________________________________________________________

Submitter's Identification (1).

Surgical Design, Inc. 7351-D Lockport Place Lorton, Va 22079 Tel#(703)541-0196 Fax#(703)541-0197

Contact Name: Mohammad Bashir - Quality Control

NAME OF THE DEVICE: (2)

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

PREDICATE DEVICE INFORMATION: (3)

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

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K04355
Page 24

EXIBIT#1

DEVICE DESCRIPTION: (4)

INTENDED USE: (5)

The Surgical Design 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.

Comparison to Predicate Devices: (6.)

	Surgical Design 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
Sterility	Non-Sterile	Sterile

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

Non Clinical testing was not performed

Discussion of Clinical Tests Performed: 8.

Clinical testing was not performed

9 Conclusions:

Surgical Design Gomco-Style Circumcision Clamp is safe and effective for it's intended use.

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Image /page/2/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 or bird-like figure, represented by three curved lines that suggest wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Mohammed Bashir Director Quality Control Surgical Design, Inc. P.O. Box 625 NEWINGTON VA 22122 Re: K043533 Trade/Device Name: Surgical Design Circumcision Clamp Regulation Number: 21 CFR 884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulatory Class: II Product Code: HFX Dated: February 28, 2005 Received: March 1, 2005

Dear Mr. Bashir:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced world 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 do not require approval or or a provisions of the Act. The general controls provisions of the Act action, sucher to goinements 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 n your do ro ro to be subject to such additional controls. Existing major regulations affecting your Apploval), it they of subject to 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 I loast of determination that your device complies with other requirements of the Act or any I DAT has made a advertisions administered by other Federal agencies. You must comply with all the I caraf suiteres and regulaing, 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) (21 CFR Part 80 7), and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

APR - 1 2005

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This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin hanceling your and equivalence of your device to a legally premarket nothleation. The I DA miding or vacion 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 If you desire specific advice for your corres on out mages, based on the regulation number at the top of this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation enation on your responsibilities under the Act from the 807.97). Tour may obtain other general miss.
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/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

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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X043533/ *

IX. Indications for Use: [Separate Page]

510(k) Number: NA K043533

Device Name: Surgical Design Circumcision Clamp

A circumcision clamp is used in a circumcision procedure to compress the foreskin of the penis during circumcision of a male infant or child.

(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 __

Nancy C broader
(Optional Format 3-10-98)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number __K043533

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.