(100 days)
Not Found
No
The document describes a mechanical circumcision clamp and explicitly states that AI, DNN, or ML were not found.
No.
Explanation: A therapeutic device is used to treat a disease or condition. This device, a circumcision clamp, is used in a surgical procedure (circumcision), which is a preventive or cultural practice, not a treatment for a disease.
No
The device is a circumcision clamp used during a surgical procedure to compress the foreskin. It does not gather information about the patient's health status or diagnose any condition.
No
The device description explicitly states it is a physical, disposable medical device constructed of Chrome Plated Brass, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. These tests are performed outside the body (in vitro).
- Device Function: The description clearly states the device is a "circumcision clamp" used to "compress the foreskin of the penis during circumcision." This is a surgical instrument used on the body during a procedure, not for testing samples from the body.
The intended use and device description are consistent with a surgical instrument, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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. A circumcision clamp is used in a circumcision procedure to compress the foreskin of the penis during circumcision of a male infant or child.
Product codes
HFX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
penis
Indicated Patient Age Range
male infant or child
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 was not performed
Clinical testing was not performed
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.
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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.
1
K04355
Page 24
EXIBIT#1
DEVICE DESCRIPTION: (4)
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.
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 Gomco
Circumcision Clamp | Centurion® CirClamp™ |
|-----------------|-----------------------------------------------------------------------------|-----------------------------------------------------------|
| Intended Use | Infant and Child
circumcision | Infant Circumcision |
| Sizes Available | Extra Small: 1.1 CM
Newborn: 1.3 CM
Infant: 1.45 CM
Child : 1.6 CM | Extra Small: 1.1 cm
Newborn: 1.3 cm
Infant: 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.
2
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
3
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
4
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