Circumcision of foreskin of males from infant to adult by circumferential excision of the foreskin or prepuce at or near the level of coronal sulcus, with minimal amount of preputial skin remaining.

Device Description

The Male Circumcision Kits: RAPIDECLAMP™ is a surgical procedure purposely for circumcision which using a set of clamps that involves partial or complete removal of the foreskin (prepuce) of the penis. This device was designed technologically using molding process to replace the conventional method. It was designed specifically to promote faster circumcision process, prevent severe bleeding with less pain. It contains a set of clamp with a protective shield, RAPIDECLAMP™ measuring plate, and a blade or scissor. This device known as RAPIDECLAMP™ is made up of Polycarbonate (PC) and Acrylonitrile butadiene styrene (ABS). Generally, RAPIDECLAMP™ consists of Guide Ring, Spike Body-Front and Rear, Anti-Slip Ring, Locking Cover, and Protective Shield.

AI/ML Overview

The provided document describes the Male Circumcision Kits: RAPIDECLAMP™. This is a medical device, and the information focuses on its substantial equivalence to predicate devices for FDA clearance, rather than a detailed efficacy study with acceptance criteria and performance metrics in the typical sense of AI/software devices.

However, I can extract information related to the device's performance based on the clinical and non-clinical tests mentioned, and present them in a format that addresses your request where applicable. It's important to note that this is not a software/AI device, so many of your requested points (like data provenance, number of experts for ground truth, MRMC studies, standalone performance for an algorithm, training set details) are not directly applicable.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Given this is a physical medical device seeking substantial equivalence, specific numerical 'acceptance criteria' for efficacy in the way one would see for an AI diagnostic tool (e.g., sensitivity > X%, specificity > Y%) are not explicitly stated in this document. Instead, the "acceptance criteria" are implied by demonstrating that the device is "safe and effective" and "substantially equivalent" to predicate devices. The performance is reported in terms of general clinical outcomes.

Criteria (Implied)	Reported Device Performance (RAPIDECLAMP™)
Safety	- Meets all safety requirements (implied by non-clinical and clinical tests). - Biocompatibility: Compliant with ISO 10993 (cytotoxicity, sensitization, and irritation requirements). - Locking Test: Confirmed that the circumcision clamp is secured properly. - Force and break tests performed on the device.
Effectiveness (Clinical Outcome)	- Easily applied in a short surgical procedure. - No suturing required. - Safe and effective means of performing circumcision on adult males. - Designed to promote faster circumcision process, prevent severe bleeding with less pain. (Claimed design goal)
Substantial Equivalence	- Substantially equivalent in clamping method, sterility, single use, no use of suture, and intended use to the predicate devices (Smart Klamp® and Shang Ring™). - Differences in design do not raise new issues of safety and effectiveness.
Materials	- Materials (Polycarbonate and ABS) meet biocompatibility requirements.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not explicitly stated. The document mentions "Clinical test were conducted" and "The clinical data collected confirms that the RAPIDECLAMP is a safe and effective means of performing circumcision on adult males." However, the exact number of patients enrolled in the clinical study is not provided in this summary.
Data Provenance: The clinical tests were conducted in Malaysia at:
- Ar-Raudhah Clinic
- JB Specialist
Retrospective/Prospective: Not explicitly stated, but clinical tests conducted at specific clinics typically imply a prospective study for device evaluation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This question is not applicable as this is a physical medical device, not an AI or software diagnostic tool that relies on expert interpretation for ground truth. The "ground truth" for a surgical device's effectiveness would be observed clinical outcomes and safety profiles in patients, assessed by the medical practitioners conducting the procedures.

4. Adjudication Method for the Test Set

Not applicable. As this is not an AI/software device requiring expert consensus on interpretations, there's no "adjudication method" in the context of resolving disagreements among experts. Clinical safety and effectiveness would be judged by treating physicians and potentially by independent review boards or regulatory bodies based on the aggregate clinical data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

Not applicable. An MRMC study is relevant for evaluating diagnostic performance of imaging systems or AI algorithms by comparing multiple readers' interpretations of cases. This device is a surgical clamp, not an interpretation tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a physical surgical instrument and inherently involves a human operator (a medical doctor). The concept of "standalone algorithm performance" does not apply.

7. The Type of Ground Truth Used

The "ground truth" for the assessment of this device's safety and effectiveness is based on clinical outcomes data gathered from the patients on whom the device was used. This would include observations related to:

Ease of application and surgical procedure time.
Prevention of severe bleeding and reported pain levels.
Post-procedure healing and absence of complications.
Overall assessment of safety and effectiveness by the medical professionals involved.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for a physical surgical device.

Summary

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

April 20, 2015

Medicfit Technology Sdn Bhd % Jigar Shah Consultant MDI Consultants. Inc. 55 Northern Blvd Great Neck, NY 11021

Re: K142163

Trade/Device Name: Male Circumcision Kits: RapideClamp™ Regulation Number: 21 CFR § 884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulatory Class: II Product Code: HFX Dated: March 17. 2015 Received: March 19, 2015

Dear Jigar Shah,

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 device

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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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Herbert P. Lerner -S

for

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

Enclosure

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Indications for Use

510(k) Number (if known) K142163

Device Name

Male Circumcision Kits: RAPIDECLAMP

Indications for Use (Describe)

Circumcision of foreskin of males from infant to adult by circumferential excision of the foreskin or prepuce at or near the level of coronal sulcus, with minimal amount of preputial skin remaining.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 201 Subpart D)	Over-The-Counter Use (21 CFR 201 Subpart C)
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Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

MEDICFIT TECHNOLOGY SDN BHD Male Circumcision Kits: RAPIDECLAMP™

Date Prepared:	April 17, 2015
Submitted by:	MEDICFIT TECHNOLOGY SDN BHD
	No31, Jalan Emas 31, Bandar Sungai Emas,42700 Banting, Selangor Darul Ehsan,Malaysia
EstablishmentNumber:	N/A
Representative:	mdi Consultants, Inc.
Proprietary Name:	Male Circumcision Kits: RAPIDECLAMP™
Common Name:	Male Circumcision Clamp
Classification Name:	Clamp, Circumcision, Obstetrics & Gynecology21 CFR § 884.4530
Product Code:	HFX

Predicate Devices:

Trade/Proprietary Name	Manufacturer	510(k) Number
Smart KlampR	Emergo Group Inc.	K032091
Shang RingTM	Wuhu Snnda MedicalTreatment ApplianceTechnology Co., Ltd	K121789

Device Description:

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It was designed specifically to promote faster circumcision process, prevent severe bleeding with less pain. It contains a set of clamp with a protective shield, RAPIDECLAMP™ measuring plate, and a blade or scissor. This device known as RAPIDECLAMP™ is made up of Polycarbonate (PC) and Acrylonitrile butadiene styrene (ABS).

Generally, RAPIDECLAMP™ consists of Guide Ring, Spike Body-Front and Rear, Anti-Slip Ring, Locking Cover, and Protective Shield.

Model Numbers and Description:

RC50308 – Male Circumcision Kits: RAPIDECLAMP™ Size: 8mm Patients: Infant to children

RC50311 – Male Circumcision Kits: RAPIDECLAMP™ Size: 11mm Patients: Infant to children

RC50314 – Male Circumcision Kits: RAPIDECLAMP™ Size: 14mm Patients: Infant to children

RC50317 – Male Circumcision Kits: RAPIDECLAMP™ Size: 17mm Patients: Teenagers to adult

RC50320 – Male Circumcision Kits: RAPIDECLAMP™ Size: 20mm Patients: Teenagers to adult

RC50323 – Male Circumcision Kits: RAPIDECLAMP™ Size: 23mm Patients: Teenagers to adult

RC50326 – Male Circumcision Kits: RAPIDECLAMP™ Size: 26mm Patients: Teenagers to adult

RC50329 - Male Circumcision Kits: RAPIDECLAMP™ Size: 29mm Patients: Teenagers to adult

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Indication For Use:

Circumcision of foreskin of males from infant to adult by circumferential excision of the foreskin or prepuce at or near the level of coronal sulcus, with minimal amount of preputial skin remaining.

Characteristic	Predicate(K032091)	Predicate(K121789)	Applicant
Intended Use	The device isindicated forcircumcisionof newborns andolder mates,defined ascircumferentialexcision of theforeskin orprepuce at ornear the level ofthe coronalsulcus, withminimal amountof preputial skinremaining.	The ShangRingdevice isindicated forcircumcision ofadult males,defined ascircumferentialexcision of theforeskin orprepuce at ornear the level orthe coronalsulcus.	Circumcision offoreskin of malesfrom infant to adultby circumferentialexcision of theforeskin orprepuce at or nearthe level of coronalsulcus, withminimal amount ofpreputial skinremaining.
Clamping method	Clamp on theforeskin toprevent severebleeding	Same	Same
Patient population	Newborn toadult males	Adult males	Infant to adultmales
Size	14 sizes (2.6,2.8, 2.9, 3.0,3.1, 3.2, 3.3,3.4, 3.5, 3.6,3.7, 3.8, 3.9,and 4.0 cm)	4 sizes (1.0, 1.3,1.6 and 2.1cm)	8 sizes (8, 11, 14,17, 20, 23, 26,29mm)
Materials	Cylinder:transparentpolycarbonateOuter clamp:nylon	Inner and outerrings:PolycarbonateSoft lining ofsurrounding	Guide ring, SpikeBody, Anti-SlipRing, ProtectiveShield:Polycarbonate
		inner ring:	Locking Cover:
		Silicone	ABS
Sterilization	Sterile	Sterile	Sterile
Single use	Yes	Yes	Yes
Need for suture	No	No	No
Removal of clamp	Remove bydoctor	Remove bydoctor	1. Automaticallydrop off afterhealed.2. Using doctor.The doctor mustbreak the safetylocks on the GuideRing (A) withpliers, unscrew theLocking Cover (D),remove the Anti-Slip Ring, cut ofgangreneoustissue, removeSpike Body (B1)and removed theGuide Ring (A)
Biocompatibility	Compliant withISO 10993	Same	Same
Mechanism ofAction	The device isclamped on theforeskin toprevent bloodflow intoprepuce	Same	Same
Dorsal Incision	The excessforeskin isincised usingmedical blade orscissor	The excessforeskin isincised usingmedical blade orscissor	The excessforeskin is incisedusing medicalblade or scissor
AdditionalInstrument	No anyadditionalinstrument. Onlya set ofSmartklamp,Size O-meter,medical scissorsor blade	No anyadditionalinstrument. Onlya set ofShangring,Specialmeasuringtape, medicalscissors orblade	No any additionalinstrument. Only aset ofRAPIDECLAMP™, measuring plateand medicalscissors or blade.

Technological Characteristics Compared To Predicate Device:

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Summary of Non-clinical Testing:

MEDICFIT TECHNOLOGY has conducted mechanical testing: Locking Test to determine a known force required to confirm that the circumcision clamp is secured properly during the use. The force and break tests were also performed on the RAPIDECLAMP.

This test was conducted to supplement the clinical data collected to demonstrate the safety and effectiveness of the RAPIDECLAMP.

All materials used in the RAPIDECLAMP have been evaluated according to tests outlined in ISO 10993-1 and meet the requirements of Bluebook Memo, General Program Memorandum G95-1 biocompatibility testing for cytotoxicity, sensitization, and irritation. The materials used are Acrylonitrile Butadiene Styrene (ABS) and Polycarbonate (PC)

Summary of Clinical Testing:

Clinical test were conducted in Malaysia at following clinics/ Hospitals:

a) Ar-Raudhah Clinic
b) JB Specialist

These studies have demonstrated that the RAPIDECLAMP is easily applied in a short surgical procedure with no suturing required. The clinical data collected confirms that the RAPIDECLAMP is a safe and effective means of performing circumcision on adult males.

Conclusions Drawn From Non-Clinical And Clinical Tests:

The results of the non-clinical and clinical tests show that RAPIDECLAMP meets all safety requirements, and is substantially equivalent in clamping method, sterility, single use, no use of suture and intended use to the predicate devices.

The data collected confirms that the differences in the design between the RAPIDECLAMP and the predicate devices do not raise any new issues of safety and effectiveness. The information and data collected support a claim of substantial equivalence of the RAPIDECLAMP to the specified predicate devices.

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.