(257 days)
Not Found
No
The device description and performance studies focus on mechanical design, materials, and clinical outcomes of a surgical clamp, with no mention of AI or ML.
Yes
The device is described as a surgical procedure for circumcision, involving the removal of the foreskin, which is a medical intervention intended to treat or prevent a condition or improve health.
No
The device is described as a surgical procedure using a set of clamps for circumcision, which involves the partial or complete removal of the foreskin. It is designed to perform a physical alteration, not to diagnose a condition.
No
The device description clearly states it is a set of physical clamps and associated components made of Polycarbonate and ABS, used for a surgical procedure. It does not mention any software components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Function: The RAPIDECLAMP™ is a surgical tool used directly on the body to perform a physical procedure (circumcision). It does not analyze any bodily fluids or tissues.
The description clearly states its purpose is for a surgical procedure and describes the physical components used in that procedure. There is no mention of analyzing samples or providing diagnostic information.
N/A
Intended Use / Indications 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.
Product codes
HFX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foreskin (prepuce) of the penis
Indicated Patient Age Range
infant to adult
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
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).
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract design featuring three stylized human profiles facing to the right, with flowing lines beneath them.
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
1
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
2
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) |
|---|---|
| ----------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
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 | |||||
| Establishment | |||||
| Number: | N/A | ||||
| Representative: | mdi Consultants, Inc. | ||||
| Proprietary Name: | Male Circumcision Kits: RAPIDECLAMP™ | ||||
| Common Name: | Male Circumcision Clamp | ||||
| Classification Name: | Clamp, Circumcision, Obstetrics & Gynecology | ||||
| 21 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 Medical | |
| Treatment Appliance | ||
| Technology Co., Ltd | K121789 |
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.
4
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
5
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 is
indicated for
circumcision
of newborns and
older mates,
defined as
circumferential
excision of the
foreskin or
prepuce at or
near the level of
the coronal
sulcus, with
minimal amount
of preputial skin
remaining. | The ShangRing
device is
indicated for
circumcision of
adult males,
defined as
circumferential
excision of the
foreskin or
prepuce at or
near the level or
the coronal
sulcus. | 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. |
| Clamping method | Clamp on the
foreskin to
prevent severe
bleeding | Same | Same |
| Patient population | Newborn to
adult males | Adult males | Infant to adult
males |
| 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:
transparent
polycarbonate
Outer clamp:
nylon | Inner and outer
rings:
Polycarbonate
Soft lining of
surrounding | Guide ring, Spike
Body, Anti-Slip
Ring, Protective
Shield:
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 by
doctor | Remove by
doctor | 1. Automatically
drop off after
healed.
2. Using doctor.
The doctor must
break the safety
locks on the Guide
Ring (A) with
pliers, unscrew the
Locking Cover (D),
remove the Anti-
Slip Ring, cut of
gangreneous
tissue, remove
Spike Body (B1)
and removed the
Guide Ring (A) |
| Biocompatibility | Compliant with
ISO 10993 | Same | Same |
| Mechanism of
Action | The device is
clamped on the
foreskin to
prevent blood
flow into
prepuce | Same | Same |
| Dorsal Incision | The excess
foreskin is
incised using
medical blade or
scissor | The excess
foreskin is
incised using
medical blade or
scissor | The excess
foreskin is incised
using medical
blade or scissor |
| Additional
Instrument | No any
additional
instrument. Only
a set of
Smartklamp,
Size O-meter,
medical scissors
or blade | No any
additional
instrument. Only
a set of
Shangring,
Special
measuring
tape, medical
scissors or
blade | No any additional
instrument. Only a
set of
RAPIDECLAMP™, measuring plate
and medical
scissors or blade. |
Technological Characteristics Compared To Predicate Device:
6
7
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.