PrePex is indicated for circumcision of adult males. Prepex is intended to be placed and removed by a health care professional trained in male circumcision and in use of the PrePex device.

Device Description

The PrePex is a device composed of three components; a plastic Inner Ring, an Elastic outer clamping Ring and a Placement Ring for applying the clamping Elastic Ring. The PrePex System is sold sterile for single use and is available in multiple sizes to accommodate variances in adult patients. A sizing guide is separately available, sold clean for single use

AI/ML Overview

Here's a summary of the acceptance criteria and study information based on the provided document:

Acceptance Criteria and Device Performance

The provided document describes the PrePex device and its clinical studies, but does not explicitly define numerical acceptance criteria in a table format for performance metrics. Instead, the "acceptance criteria" are implicitly demonstrated through the study results showing safety and efficacy, and comparison to a predicate device.

However, based on the information provided, we can infer some performance indicators and present them in a table, noting that these are reported results, not pre-defined acceptance thresholds:

Performance Metric	Reported PrePex Performance
Complete Circumcision	Achieved in all 50 subjects (First Study)
Bleeding Cases	0 (First Study)
Unexpected Adverse Events	0 (First Study)
Device-Related Incidents	0 (First Study)
Instances of Erroneous Placements	0 (First Study)
Average Total Procedure Time	3 minutes, 11 seconds (Second Study)
Related Adverse Events (AEs)	0 (Second Study, PrePex arm)
Unrelated AEs (mild)	3 (Second Study, PrePex arm)
Unrelated AEs (moderate)	1 (Second Study, PrePex arm)
Average Procedure Preparation Time	3 minutes, 24 seconds (Second Study)
Average Time to Complete Healing	38 days post device removal (Second Study)
Serious Adverse Events	0 (Across all clinical studies)
Pain levels (at placement)	Minimal (First Study)
Pain levels (at device removal)	Moderate initially, resolved with oral analgesia (First Study)
Biocompatibility	Passed (negative results for cytotoxicity, dermal irritation, dermal sensitization)
Bench Testing	Successfully passed (Delivery Ring Test, Elastic Ring Elongation Test, Inner Ring Surface Smoothness Test, Final Product Measurements Test)

Study Information

Here's the detailed study information based on the provided text:

Sample sizes used for the test set and the data provenance:
- First Study: 50 healthy uncircumcised men aged 18 to 35 years. Data provenance: Retrospective - initiated and sponsored by the government of Rwanda. (The phrase "initiated and sponsored by the government of Rwanda" suggests the data was collected in Rwanda, but doesn't explicitly state the country of origin of all participants' data if some were referred from elsewhere, though highly probable to be Rwanda.)
- Second Study: 180 participants, randomly divided into 2 unbalanced study arms:
  - PrePex arm: 120 subjects
  - Surgical circumcision arm: 60 subjects
- Data provenance: Prospective, randomized, comparative study. Sponsored by the Government of Rwanda. (Implies data collected in Rwanda.)
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- First Study: "The device was placed and removed by a physician or a nurse..." and "experienced operators who participated in the first study" performed procedures in the second study. While not explicitly stated how many experts established the ground truth, the "physician or a nurse" and "experienced operators" indicate medical professionals were assessing outcomes. The document does not specify the exact number of experts or their specific qualifications (e.g., years of experience, specialization) beyond "physician or a nurse" and "surgeon highly experienced in adult male circumcision."
- Second Study: "All PrePex Device procedures were performed by experienced operators who participated in the first study." "The surgical circumcision procedure used was the dorsal slit method which was performed by a surgeon highly experienced in adult male circumcision." Similar to the first study, specific numbers and complete qualifications of "experts" for ground truth are not detailed beyond "experienced operators" and "highly experienced surgeon."
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document does not describe an explicit adjudication method (like 2+1 or 3+1 consensus) for the test set's outcomes. Outcomes appear to be directly observed and recorded by the medical professionals involved in the study (physicians, nurses, experienced operators, surgeons).
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:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a manual medical instrument for a surgical procedure, not an AI or imaging diagnostic tool that would involve "human readers" interpreting data with or without AI assistance. The comparative study was between two different circumcision methods: PrePex device vs. surgical circumcision.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, this is a medical device (clamp) used for a procedure, not an algorithm. Therefore, a standalone algorithm performance study is not applicable. The performance is inherently "with human-in-the-loop" as it requires a healthcare professional.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth was based on clinical outcomes data and expert observation/assessment by healthcare professionals. This includes:
  - Achieving complete circumcision.
  - Absence of bleeding.
  - Adverse event rates (observed and recorded by medical staff).
  - Procedure times, preparation times, and healing times (measured outcomes).
  - Pain assessment (patient-reported via VAS, but assessed/monitored by clinicians).
The sample size for the training set:
- This is a medical device, not an AI algorithm that requires a "training set" in the machine learning sense. Therefore, this question is not applicable. The "training" for the device would involve healthcare professionals being trained in its use.
How the ground truth for the training set was established:
- As there is no "training set" in the AI sense, this question is not applicable.

Summary

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JAN 1 0 2012

510(K) Summary

[as required by section 807.92(c)] PrePex

510(k) Number K103695

Date:

January 6, 2012

Applicant Name:

Circ MedTech 6 Hahoshlim St, First floor P.O Box 12006, Herzeliah 46722 Israel Phone: +972 7 76935607 Fax:

Company Contact:

Alon Kushnir, VP Regulations and Clinical Affairs Phone: +972 7 76935607 Email: alon@c-medtech.com

Contact Person:

Shoshana (Shosh) Friedman, RAC Address: 1914 ] N Pease Pl., Charlotte, NC 28262 Telephone: 704-430-8695 or 704-899-0092 Fax: 704-899-0098 E-mail: shosh@pushmed.com

Trade Name:

PrePex

Classification Name:

Clamps, Circumcision, Obstetric-gynecologic specialized manual instrument

Classification:

FDA has classified circumcision clamps for specific uses as class II devices (product code HFX) and they are reviewed by the Obstetric-Gynecologic review committee.

Reason for Submission:

New device

Predicate Devices:

Smart Klamp* Circumcision Clamp (Emergo Group, Inc.) cleared under K032091

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Device Description:

Intended Use:

PrePex is indicated for circumcision of adult males. PrePex is intended to be placed and removed by a health care professional trained in male circumcision and in use of the PrePex device.

Technological Characteristics:

The device is designed to block blood supply to the foreskin by clamping the foreskin between the outer Elastic Ring and the Inner Ring. The device remains on the patient foreskin until the physician determines to remove the foreskin. This can be immediate, after placing the device and up to 1 week later when the device is removed.

Performance Pre-Clinical Data:

The PrePex has been subject to biocompatibility testing per ISO 10993-. 1:2009 and FDA Blue Book Memorandum #G95-1 (cytotoxicity, dermal irritation, dermal sensitization). The results of these tests were negative and support the safe use of the PrePex in contact with non-intact skin.
. The PrePex successfully passed a series of bench tests including Delivery Ring Test, Elastic Ring Elongation Test, Inner Ring Surface Smoothness Test, and Final Product Measurements Test.

Performance Clinical Data:

The PrePex Device was subject to a clinical study initiated and sponsored . by the government of Rwanda. The objectives of the study were to assess the safety and efficacy of the PrePex Device for nonsurgical circumcision in adult males. A total of 50 healthy uncircumcised men aged 18 to 35 years were enrolled. The device was placed and removed by a physician or a nurse in a non-sterile setting, with no need for anesthesia or suturing. The subjects were seen regularly throughout the 6-week study, with pain assessed using a visual analog scale (VAS) at each visit. The results of this study show that all subjects achieved the endpoint of complete circumcision with no cases of bleeding and no unexpected
adverse events related to the procedure or the device. Only 1 case of diffuse edema, which was resolved with minimal intervention (Ibuprofen), was reported following device removal. All subjects returned to their daily routines soon after device placement and removal, with no sick/absent days associated with the procedure. The median time for complete healing was 21 days after device removal, i.e., 28 days post-placement; the mean time was 25.3 days after device removal. There were no devicerelated incidents, the device functioned as expected in all subjects and there were no instances of erroneous placements of the device.

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As a result of the above mentioned study, the Government of Rwanda . sponsored a second study in which the performance of the PrePex device was compared to a WHO approved method of surgical circumcision in a prospective, randomized, comparative study. The study included a total of 180 participants randomly divided into 2 unbalanced study arms: PrePex arm of 120 subjects and surgical circumcision arm of 60 subjects. The study period per subject was 9 weeks.
The primary objective of the study was to assess the total operative time of the PrePex Device circumcision procedure versus the total operative time of surgical circumcision procedure, as defined in the Framework for Clinical Evaluation of Devices for Adult Male Circumcision (February 2011). Additionally, a number of secondary objectives were evaluated amongst them were: clinical adverse event rates, procedure preparation time and time to complete healing.

All PrePex Device procedures were performed by experienced operators who participated in the first study. The procedures were carried out in a clean environment in a minor surgery room. The procedure was bloodless, and was conducted with no anesthesia or sutures. Subjects participated in regular follow-up visits at specified intervals.

The surgical circumcision procedure used was the dorsal slit method which was performed by a surgeon highly experienced in adult male circumcision.

The study vielded the following results:

o The average PrePex total procedure time of 3 minutes and 11 seconds is much shorter than the surgical circumcision (15 min. and 33 sec.).
There were NO related AEs in the PrePex study arm compared to o 7 related mild AEs in the surgical arm.
There were 3 mild un-related AEs and 1 moderate un-related AE o in the PrePex arm and 1 moderate un-related AE in the surgical arm.
The average procedure preparation time was 3min and 24 sec for o the PrePex procedure compared to 8 min and 50 sec for the surgical procedure.
Average time to complete healing was 38 days post PrePex device o removal and 30 days post surgery.

Adverse Events

In the clinical studies there were no serious adverse events related to the PrePex device or the PrePex procedure.

In the first study, subjects reported minimal pain at all steps in the process except device removal. During device removal subjects experienced moderate pain, therefore, after the first 20 subjects, a 1-g dose of oral analgesia approximately 30 minutes before device placement and before device removal was administered. No additional painkiller was required in any subject.

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Substantial Equivalence:

Substantial Equivalence
Characteristic	SmartKlamp	PrePex
Intended use	indicated forcircumcision ofnewborns and oldermales, defined ascircumferential excisionof the foreskin orprepuce at or near thelevel of coronal sulcus,with minimal amountof preputial skinremaining	indicated for circumcisionof adult malesintended to be placed andremoved by a health careprofessional trained inmale circumcision and inuse of the PrePex device
Location of use	Foreskin	Foreskin
Target population	Male newborn andadult	Male adult
Mode of operation	Blocks blood supply tothe foreskin byclamping the foreskin	Blocks blood supply tothe foreskin byclamping the foreskin
Mode of use	Single use	Single use
Material made	Plastic	Plastic
Accessories	Sizing device	Sizing device
Sizes	Sizes range from 10mmto 25mm of diameter	Sizes from 26mm to36mm of diameter

Conclusion:

Circ MedTech believes that, based on the information provided in this submission, the PrePex is substantially equivalent to its predicate device without raising any new safety and/or effectiveness issue.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three legs and a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the border of the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Circ MedTech % Ms. Shoshana (Shosh) Friedman President & CEO PushMed LLC 1914 J.N. Pease Place CHARLOTTE NC 28262

JAN 1 0 2012

Re: K103695

Trade/Device Name: PrePex Regulation Number: 21 CFR§ 884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulatory Class: II Product Code: HFX Dated: November 16, 2011 Received: November 23, 2011

Dear Ms. Friedman:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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); medical device reporting (reporting of medical

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Page 2 -

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Benjamin K. Reese

Benjam R. Fisher, Ph.D., Director Division of Reproductive, Gastro-Renal, and Grological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number (if known): _ K103695

PrePex Device Name:

Indications for Use:

PrePex is indicated for circumcision of adult males. Prepex is intended to be placed and removed by a health care professional trained in male circumcision and in use of the PrePex device.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)

Over the Counter Use_

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Norm M. Whing
(Division Sign-Off)

. and

PrePex - Page 5-2

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.