PURITAN FOAM TIP SWAB MODEL 2197 by HARDWOOD PRODUCTS CO., LP

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.

AI/ML Overview

This document, K961934, is a 510(k) Summary of Safety and Effectiveness for the Puritan Foam Tip Swab, dated July 9, 1996. It describes a medical device, not an AI/ML device, and therefore does not contain the information requested in your prompt regarding acceptance criteria and studies for AI/ML performance.

The document outlines the following:

Device: Puritan Foam Tip Swab
Intended Use: To obtain a Pap smear sample from the endocervix.
Predicate Devices: Absorbent Tip Applicator (Hardwood Products Co. K902338) and Cell Collecting Brush (Anderson Winn Paper Co. K924908).
Non-clinical tests: Biocompatibility of polyurethane foam and tip adhesion testing (showing comparability to the Cell Collecting Brush).
Functional Clinical Performance: A study comparing Pap smears from the Puritan Foam Tip Swab to the Cell Collecting Brush, concluding that the new device is "as effective... for obtaining and transferring to a slide cervical cytological specimens that are adequate for diagnosis."

Since the device is a physical medical swab and not an AI/ML diagnostic tool, the requested information regarding AI/ML acceptance criteria, study details (sample sizes for test/training sets, data provenance, expert qualifications, adjudication, MRMC studies, standalone performance), and ground truth establishment methods for AI/ML are not applicable and not present in this document.

Summary

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Image /page/0/Picture/0 description: The image shows the text "HARDWOOD PRODUCTS COMPANY" in a bold, sans-serif font. The text is arranged horizontally and is the primary focus of the image. The words are evenly spaced and the overall impression is clean and professional.

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

TELE ('HONE (207) 876-3311 · 1-800-321-2313 FAX: (207) 876-3130 · 1-800-323-4153

K961934

JUL. 9 1996

TROPHY

APPENDIX III

510 (k) Summary of Safety and Effectivess

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

1 . Hardwood Products Co. Submitted by : P.O. Box 149, School St. Guilford, Me 0443-0149
2 . William M. Young, QC Manager Contact Person: 207-876-3311 Fax 207-876-3130
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)

1. The Puritan Foam Tip Swab consists of a Device Description: polyurethane foam tip bonded to a high impact polystyrene shaft with hot melt adhesive. The device is for single use only and non-sterile.
1. Intended Use: The Puritan Foam Tip Swab is used to obtain a Pap smear sample from the endocervix.
1. Device Comparison: The Puritan Foam Tip Swab is similar to the cell collecting brush for materials, construction, and dimensions.
1. Non-clinical tests: Polyurethane foam has been shown to be biocompatable. 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.

Regulation Number and Section

§ 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.