CIRCUMCISION TRAY, CAT. NO. 70340

K974286 · Trinity Laboratories, Inc. · HFX · Dec 12, 1997 · Obstetrics/Gynecology

Device Facts

• Record ID: K974286
• Device Name: CIRCUMCISION TRAY, CAT. NO. 70340
• Applicant: Trinity Laboratories, Inc.
• Product Code: HFX · Obstetrics/Gynecology
• Decision Date: Dec 12, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4530
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Trinity's Circumcision Tray is a sterile prepackaged disposable unit. It contains the gauze sponges, straight mosquito forceps, curved mosquito forceps, adson tissue forceps, probe wtih eye, PVP swabsticks, OR scissors, multi-compartment pouch, #10 blade scalpel, and fenestrated cloth OR towel necessary for the performance of the circumcision surgical procedure..

Device Story

Circumcision Tray is a sterile, prepackaged, disposable surgical kit. It contains various manual instruments including gauze sponges, mosquito forceps (straight and curved), adson tissue forceps, probe with eye, OR scissors, #10 blade scalpel, multi-compartment pouch, and fenestrated cloth OR towel. The device is used in a clinical or surgical setting by a physician to perform a circumcision. The kit provides the necessary tools in a single, convenient package to facilitate the surgical procedure. The inclusion of PVP swabsticks is noted as a drug component subject to separate regulatory oversight.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

The device is a manual surgical instrument kit. It consists of standard surgical tools (forceps, scissors, scalpel, probe) and supplies (gauze, cloth, pouch). It is provided sterile. No electronic, software, or complex mechanical components are described.

Indications for Use

Indicated for use as a sterile, prepackaged disposable kit containing instruments and supplies necessary for performing a circumcision surgical procedure.

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Partha Basumallik Vice President Trinity Laboratories, Inc. 201 Kiley Drive Salisbury, MD 21801

DEC 1 2 1997

Re: K974286 Circumcision Tray Regulatory Class: II Product Code: 85 HFX; CFR 884.4530 Dated: November 11, 1997 Received: November 14, 1997

Dear Mr. Basumallik:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 (the Act). You may, therefore, market the device, subject to the general controls provisions of Act. However, you are responsible to determine that the medical devices you use as components in the tray have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your tray. 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 additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections. FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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## Page - 2 - Mr. Partha Basumallik

In addition, we have determined that your device kit contains PVP Swabsticks which are subject to regulation as a drug.

Our substantially equivalent determination does not apply to the drug component of your device. We recommend you first contact the Center for Drug Evaluation and Research before marketing your device with the drug component. For information on applicable Agency requirements for marketing this drug, we suggest you contact:

Director, Division of Drug Labeling Compliance (HFD-310) Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857 [phone]

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results 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 and additionally 809 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act, may be obtained from the Division of Small Manufacturers Assistance at its toll free number [phone] or [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Robert R Ratting /

Lillian Yin, Ph.D. Director, Division of Reproductive, ... ............ Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510 (k) Number (if Known): K974286

Device Name: Circumcision Tray

Indications for Use:

Trinity's Circumcision Tray is a sterile prepackaged disposable unit. It contains the gauze sponges, straight mosquito forceps, curved mosquito forceps, adson tissue forceps, probe wtih eye, PVP swabsticks, OR scissors, multi-compartment pouch, #10 blade scalpel, and fenestrated cloth OR towel necessary for the performance of the circumcision surgical procedure..

ON THE

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 __

Robert D. Satling

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K971286

(Optional Format 1-2-96) -------