MEDLINE CIRCUMCISION TRAY

K970282 · Medline · HFX · Mar 6, 1997 · Obstetrics/Gynecology

Device Facts

• Record ID: K970282
• Device Name: MEDLINE CIRCUMCISION TRAY
• Applicant: Medline
• Product Code: HFX · Obstetrics/Gynecology
• Decision Date: Mar 6, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4530
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Medline Circumcision Trays are intended for use by licensed physicians. The intended use of the medical products assembled in these kits will not be changed from the manufacturer's original intended use.

Device Story

Medline Circumcision Trays consist of custom-assembled medical devices, drugs, and non-medical materials used by physicians during circumcision procedures. Contents, quantities, and brands are specified by the customer. Trays are assembled in a class 10,000 clean room and sterilized via EtO or gamma radiation. The device serves as a procedural kit to organize necessary components for the clinician; it does not alter the intended use of individual components.

Clinical Evidence

Bench testing only; no clinical data provided. Equivalence is based on the regulatory status of individual components.

Technological Characteristics

Custom-assembled kit of medical devices, drugs, and packaging materials. Assembly in class 10,000 clean room. Sterilization via EtO or gamma radiation.

Indications for Use

Indicated for use by licensed physicians during circumcision procedures.

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.

Predicate Devices

• Baxter Disposable Circumcision Tray (K884290)

Submission Summary (Full Text)

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MEDLINE
Medline Industries, Inc.
One Medline Place
Mundelein, Illinois 60060.4486
1.847.949.3109
1.800.950.0128
Fax [phone]

# Corporate Quality Assurance/Regulatory Affairs

## SUMMARY OF SAFETY AND EFFECTIVENESS

K970282
P192
MAR - 6 1997

January 22, 1997

Medline Industries, Inc.
One Medline Place
Mundelein, IL 60060
Registration #: 1417592
Phone: [phone] x1131
Fax: [phone]
Christine M. Galea
Corporate Regulatory Affairs

DEVICE NAME: Circumcision Trays
PROPRIETARY NAME: Medline Circumcision Trays
COMMON NAME: Circumcision Trays
PERFORMANCE STANDARDS: None per Section 514

### CLASSIFICATION NAME:

We have been unable to locate specific classifications for these devices. The contents of each tray are either Class I or Class II medical devices, drugs or non-medical materials (i.e. packaging, cartons and labels).

### PRODUCT SPECIFICATIONS

Medline Circumcision Trays are an assemblage of medical materials to be used by medical professionals during circumcision procedures. The trays will be assembled using Medline and other manufacturer's materials, medical devices and/or drugs.

The devices are custom to our customers who specify the contents, quantity and placement of the individual items in the tray. The customer may also specify a specific brand of similar items or minor variations of items.

Medline intends to assemble these kits in a class 10,000 clean room or controlled environment and to sterilize using either EtO or gamma radiation at a contracted sterilization facility.

### INTENDED USE/INDICATIONS FOR USE

Medline Circumcision Trays are intended for use by licensed physicians. The intended use of the medical products assembled in these kits will not be changed from the manufacturer's original intended use.

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MEDLINE

Medline Industries, Inc.
One Medline Place
Mundelein, Illinois 60060.4486
1.847.949.3109
1.800.950.0128
Fax [phone]

# Corporate Quality Assurance/Regulatory Affairs

K970282
8272

## SUMMARY OF SAFETY AND EFFECTIVENESS (cont.)

### SUBSTANTIAL EQUIVALENCE

We certify that components or individual items of the assembled device have been on the market prior to May 28, 1976, or have been shown by their manufacturer to be substantially equivalent to pre-amendment devices, or to be exempt from 510(k) notification requirements.

The component list attached as Exhibit A includes the name and regulatory status of the intended components used in these trays. We do not expect this list to change, however, if additional components and/or manufacturers must be added, we will certify the regulatory compliance of the added devices, and keep the information in our Master Device Record.

Many companies assemble various medical devices into a kit or tray for specific medical procedures. Similar procedure specific kits, such as K884290, Baxter Disposable Circumcision Tray, are in commercial distribution and are marketed by Baxter Healthcare, located in Waukegan, Illinois.

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