EOS BRAND DISPOSABLE CYTO/CERVICAL SAMPLER

K963685 · North Eos Industries, Inc. · HHT · Oct 11, 1996 · Obstetrics/Gynecology

Device Facts

• Record ID: K963685
• Device Name: EOS BRAND DISPOSABLE CYTO/CERVICAL SAMPLER
• Applicant: North Eos Industries, Inc.
• Product Code: HHT · Obstetrics/Gynecology
• Decision Date: Oct 11, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4530
• Device Class: Class 2

Indications for Use

The device is used for Pap.s. for scraping and removing the cytological material from the surface of the cervix or vagina.

Device Story

Disposable cervical sampler (EosSmear); Ayer's spatula design with screw round top and scraping back; used by physicians/nurses in clinical settings for Pap smear collection; device scrapes cervical/vaginal surface to collect cytological material; manual operation; disposable; sterilized via GAMMA radiation; provides safe, hygienic collection of samples for diagnostic evaluation.

Clinical Evidence

Bench testing only. Material testing confirmed absence of heavy metals. Sterility testing confirmed safety and hygiene following GAMMA radiation sterilization.

Technological Characteristics

Disposable cervical spatula; plastic construction; screw round top design; manual operation; sterilized via GAMMA radiation.

Indications for Use

Indicated for patients undergoing cervical or vaginal cytological sampling (Pap smears) for the collection of cellular material.

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.

Reference Devices

• Ayer's spatula (wooden)
• Ayer's spatula (plastic)
• Cyto-Brush (U.K.)
• cervi-brush
• Endocervical sampler
• Cotton Swab
• CytoPick (Japan)
• Gynoscann (Portugal)
• Spatulas and cotton Swabs (Paul Boettger)
• Cyto-spatula (Switzerland)

Submission Summary (Full Text)

{0}

OCT 11 1996

EOS

NORTH EOS INDUSTRIES, INC.

54, LANE 1, BEEN STREET, P.O.BOX 22

TUNG SHIH, TAICHUNG HSIEN 423

TAIWAN, R.O.C.

TELEPHONE: [phone] FAX: [phone]

K963685

Classification ; EOS Brand Disposable Cyto/Cervical Sampler

Common name ; EosSmear

Brand name ; EOS Brand

Registration ; #8043235

Class I

DATE: AUG.28,1996

REF. :

510(k) SUMMARY

The device has the same intended use and technological characteristics as the legally premarketed devices. Its usage, mode of action are equivalent to the legally premarketed devices.

We indicate devices that premarketed world widely, the devices also called by people among medical fields, like, doctors, nurses, medical traders purchasers of the medical products, etc., they are commonly used in the hospitals for Pap.s.,

And our this device is the same purpose used for Pap.s. as the premarketed devices which we mentioned as followings;

Ayer's spatula (wooden), made in many countries the same type

Ayer's spatula (plastic)

Cyto-Brush made in U.K.

cervi-brush

Endocervical sampler

Cotton Swab also supplied by countries.

CytoPick Japan

Gynoscann Portugal

Spatulas and cotton Swabs Germany (Paul Boettger ong company)

Cyto-spatula for cervical smear made in Switzerland

The device-EosSmear is the Ayer's spatula type with screw round top for easily scraping and removing the cytological material from the surface of the cervix or vagina; and the back of the design is for scraping also of the cervical area and SCJ part of the body.

The device is not a special or very new device, but a common and same type, traditional device that used for Pap. s.. As in the world the spatula is not a special one, people supply the same-premarketed devices as Ayer's spatula in wooden or plastic materials, or Cyto-brush types but with their own brand name, so as the EosSmear is the same usage, intended use, same safety and effectiveness for which is the substantial equivalence to the premarketed devices, disposable, low cost and light weight.

The cervical spatula, some doctors used with sterilized, or non-sterilized. As it touches the body surface at very short time, so we made tests of material test which shows non-heavy metal contents of our device; and the sterility test proves the device is safe and hygiene, no harm to patients due to the sterilization by GAMMA Radiation is approved.