PURITAN FOAM TIP SWAB MODEL 2197

K961934 · Hardwood Products Co., LP · HHT · Jul 9, 1996 · Obstetrics/Gynecology

Device Facts

• Record ID: K961934
• Device Name: PURITAN FOAM TIP SWAB MODEL 2197
• Applicant: Hardwood Products Co., LP
• Product Code: HHT · Obstetrics/Gynecology
• Decision Date: Jul 9, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4530
• Device Class: Class 2

Indications for Use

The Puritan Foam Tip Swab is used to obtain a Pap smear sample from the endocervix.

Device Story

Device consists of polyurethane foam tip bonded to high-impact polystyrene shaft via hot melt adhesive; single-use; non-sterile. Used by clinicians to collect endocervical cells for Pap smear analysis. Device facilitates specimen collection and transfer to slide for cytological diagnosis. Benefits include effective cell retrieval comparable to existing cell collecting brushes.

Clinical Evidence

Comparative study of Pap smears obtained via subject device versus predicate cell collecting brush. Results demonstrated subject device is as effective as predicate for obtaining and transferring cervical cytological specimens adequate for diagnosis.

Technological Characteristics

Materials: Polyurethane foam tip, high-impact polystyrene shaft, hot melt adhesive. Form factor: Swab/applicator. Single-use, non-sterile. Biocompatibility established via MAF#139.

Indications for Use

Indicated for obtaining endocervical Pap smear samples for cytological diagnosis in patients requiring cervical screening.

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

• Absorbent Tip Applicator (K902338)
• Cell Collecting Brush (K924908)

Submission Summary (Full Text)

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Puritan

Gold Bond STICKS AND SPOONS

TROPHY

WOODENWARE

HARDWOOD PRODUCTS COMPANY

GUILFORD, MAINE 04443-0149 U.S.A.

TELEPHONE [phone] · 1-800-321-2313

FAX: [phone] · 1-800-323-4153

JUL 9 1996

K961934

## APPENDIX III

## 510(k) Summary of Safety and Effectiveness

This Summary of is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 870.92

1. Submitted by: Hardwood Products Co.
P.O. Box 149, School St.
Guilford, Me 0443-0149

2. Contact Person: William M. Young, QC Manager
207-876-3311
Fax [phone]

3. Trade Name: Puritan Foam Tip Swab
Common Name: Foam tip swab/applicator
Classification Name: Cervical cytological spatula

4. Predicate Devices: Absorbent Tip Applicator (Hardwood Products Co. K902338)
Cell Collecting Brush (Anderson Winn Paper Co. K924908)

5. Device Description: The Puritan Foam Tip Swab consists of a polyurethane foam tip bonded to a high impact polystyrene shaft with hot melt adhesive. The device is for **single use** only and **non-sterile**.

6. Intended Use: The Puritan Foam Tip Swab is used to obtain a Pap smear sample from the endocervix.

7. Device Comparison: The Puritan Foam Tip Swab is similar to the cell collecting brush for materials, construction, and dimensions.

8. Non-clinical tests: Polyurethane foam has been shown to be biocompatible. Test reports are attached and available in Device Master File, MAF#139. Tip adhesion testing has shown the Puritan Foam Tip Swab comparable to the Cell Collecting Brush.

9. Functional Clinical Performance: A study of Pap smears from each device showed the Puritan Foam Tip Swab to be as effective as the Cell Collecting Brush for obtaining and transferring to a slide cervical cytological specimens that are adequate for diagnosis.

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