(65 days)
The GMD Circumcision Clamp is intended to be used in the medical procedure of circumferential excision of the foreskin or prepuce skin at or near the level of coronal sulcus, with minimal amount of preputial skin remaining.
The GMD Circumcision Clamp is a stainless steel reusable medical device intended to be used in circumcision procedures. The GMD Circumcision clamp will be sold non-Sterile.
The provided 510(k) summary for the GMD Universal Circumcision Clamp does not contain information about acceptance criteria or a study proving the device meets them.
Instead, the document states:
"The company did not conduct, nor depend on, clinical studies or non-clinical laboratory studies in order to establish substantial equivalence as this type of technology and procedure has a long history of clinical use."
This indicates that the device's substantial equivalence was established based on its similarity to a legally marketed predicate device (GOMCO Circumcision Clamp - K894201) and the long history of clinical use of this type of technology, rather than through performance-based acceptance criteria and a specific study.
Therefore, the requested tables and details regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, and MRMC studies cannot be extracted from this document as they are not present.
In summary, none of the specific information requested regarding acceptance criteria and performance studies is available in the provided text. The 510(k) submission relied on substantial equivalence to a predicate device and existing clinical history rather than new performance data.
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510(K) Summary
Introduction
This 510(k) summary documentation is intended to comply with requirements of 21 CFR § 807.92. FDA may make this summary available to the public within 30 days following a finding of substantial equivalence.
510K Submitted By
Generic Medical Device, Inc. 2201-34th Ave NW Gig Harbor, WA 98335
USA Contact Person
Monica R. Montanez, RAC, CQA Consultant Tel: 713-523-9630 / Fax: 713-521-2770
Date Prepared
November 5, 2006
Trade Name of Device
GMD Universal Circumcision Clamp
Proprietary Name:
GMD Universal Circumcision Clamp
Common Name:
Clamp, Circumcision
Classification Name:
Clamps, Circumcision Class II: Obstetric-gynecologic specialized manual instrument 21 CFR 884.4530, Product Code HFX.
Predicate Devices:
K894201 - GOMCO Circumcision Clamp Manufactured by: Zinnanti Surgical Instruments 21540-B Prairie Street Chatsworth, California 91311
510(k) Classification Class II
Device Description
JAN / 7 2007
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The GMD Circumcision Clamp is a stainless steel reusable medical device intended to be used in circumcision procedures. The GMD Circumcision clamp will be sold non-Sterile.
Intended Use
The GMD Circumcision Clamp is intended to be used in the medical procedure of circumferential excision of the foreskin or prepuce skin at or near the level of coronal sulcus, with minimal amount of preputial skin remaining.
Comparison to Predicate Devices
GMD Universal Circumcision Clamp has the same intended use, same technological characteristics as the predicate device (GOMCO Circumcision Clamp- K894201). The GMD Universal Circumcision Clamp and the GOMCO device are substantially equivalent in their method of circumcision as they both crush the prepuce parallel to the axis of the penis. They are also equivalent in intended use as they are both are used for circumferencial crushing of the prepuce to achieve circumcision.
Clinical/Non-Clinical Studies
The company did not conduct, nor depend on, clinical studies or non-clinical laboratory studies in order to establish substantial equivalence as this type of technology and procedure has a long history of clinical use.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular fashion around the caduceus. The logo is black and white.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Generic Medical Device Company c/o Ms. Monica Montanez Consultant Montanez and Associates 3906 Roseland St. HOUSTON TX 77006
JAN 1 7 2007
Re: K063429
Trade/Device Name: GMD Universal Circumcision Clamp Regulation Number: 21 CFR §884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulatory Class: II Product Code: HFX Dated: November 11, 2006 Received: November 13, 2006
Dear Ms. Montanez:
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 (Premarket Approval), it may be subject to such 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.
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Protesting and Promoting Public Health.
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Page 2 -
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I least be advised that I Dris lessant that your device complies with other requirements of the Act that I Dri has made a and regulations administered by other Federal agencies. You must or any I odolar battler and streegirements, including, but not limited to: registration and listing (21 Comply with an the Hot STEQUES Part 801); good manufacturing practice requirements as set CI K Part 6077, adoling (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w you to substantial equivalence of your device of your device to a legally premarker notinodion: "The states 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 this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
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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Indications for Use GMD UNIVERSAL CIRCUMCISION CLAMP
K063429 510(k) Number (if known):
Device Name: GMD Universal Circumcision Clamp
Indications For Use: The GMD Circumcision Clamp is intended to be used in the medical procedure of circumferential excision of the foreskin or prepuce skin at or near the level of coronal sulcus, with minimal amount of preputial skin remaining.
Prescription Use X (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)
Nancy C Brogdon
(Division Sign Off)
Division
and
510(k) Number K063429
§ 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.