GYN Disposables Tenaculum 356T is made of glass reinforced polycarbonate. The GYN Disposable Tenaculum is supplied in a Tyvek pouch and has been sterilized by gamma radiation.

AI/ML Overview

The GYN Disposables Tenaculum 356T is a medical device used to snare, grasp, hold, and manipulate cervical and intravaginal tissue. The device is made of glass-reinforced polycarbonate and is supplied sterile by gamma radiation.

Here's an analysis of the acceptance criteria and the studies that demonstrate the device meets them:

Acceptance Criteria and Reported Device Performance

The document describes several tests conducted to ensure the device's safety and performance. The acceptance criteria are generally qualitative (e.g., "met the minimum acceptance criteria," "did not induce cytotoxicity," "passed").

Test Category	Acceptance Criteria	Reported Device Performance
Material Strength	The advanced composite design can easily withstand forces during normal use. The instrument met the minimum acceptance criteria for flexibility, arm strength, tip strength, rack strength, force needed to lock, and hinge pin strength. Does not degrade due to gamma sterilization and extended shelf life.	All test reports (flexibility & arm strength, tip strength, rack strength & locking force, hinge pin strength) showed that the instrument met the minimum acceptance criteria. These tests proved that the material does not degrade because of gamma sterilization and extended shelf life.
Biocompatibility	Cytotoxicity: No induction of cytotoxicity relative to positive and negative controls. Pyrogenicity/Sensitization/Irritation: No increase in temperature (in rabbits). Hemolysis: No damage to blood cells. Dermal Sensitization: Passed (in guinea pig). Systemic Toxicity (Acute): Passed (in mouse). Intracutaneous Irritation: Passed (in rabbit). Vaginal Irritation: Passed (in rabbit). All tests meet and exceed criteria established in FDA's 510(k) Memorandum #G95, Table 1 for minimal contact duration (<24 hours), "External Communicating Device", and "Blood Path, Indirect" classification.	Cytotoxicity: The test article did not induce cytotoxicity. Pyrogenicity/Sensitization/Irritation: The as-made instrument did not cause any increase in temperature. Hemolysis: The average % hemolysis was determined to be 0.0%, meaning that the extract did not cause damage to blood cells. Dermal Sensitization: GYN material passed. Systemic Toxicity (Acute): GYN material passed. Intracutaneous Irritation: GYN material passed. Vaginal Irritation: GYN material passed. These seven tests meet and exceed the criteria established in FDA's 510(k) Memorandum #G95, Table 1.
Sterilization	Product qualification for irradiation sterilization met acceptance criteria (Initial verification dosing, bioburden, bacteriostasis/fungistis, sterility testing).	Acceptance criteria were met for initial verification dosing, bioburden, bacteriostasis/fungistis, and sterility testing.
Packaging Integrity	Product packaging met requirements of burst test at non-aged and 1-year accelerated aged time point. Product packaging met requirements of dye penetration test both non-aged and 1-year aged.	The product packaging met the requirements of the burst test at the non-aged and 1 year accelerated aged time point. Product packaging met the requirements of the dye penetration test both non-aged and 1 yr aged.

Study Information

2. Sample sizes used for the test set and the data provenance:

Material Strength Tests: The document doesn't explicitly state the sample size for each individual strength test (flexibility, arm strength, tip strength, rack strength, hinge pin strength). It mentions testing "non sterile, gamma sterilized non-aged, and gamma sterilized aged product" in four ways. This implies multiple samples for each condition.
Biocompatibility Tests:
- In vitro cytotoxicity: Not specified, but standard lab practices involve replicates.
- Pyrogen test: Rabbits (number not specified, but typically N=3 for such tests).
- Hemolysis test: Rabbit blood (sample size not specified).
- Dermal sensitization: Guinea pig (number not specified, but typically N=10 for main study).
- Systemic toxicity: Mouse (number not specified, but typically N=10 for main study).
- Intracutaneous irritation: Rabbit (number not specified, but usually N=2 for a primary irritation test).
- Vaginal irritation: Rabbit (number not specified, but usually N=3 or N=5).
Sterilization Validation: Not specified, but determined by ANSI/AAMI/ISO 11137-2:2006 guidelines.
Packaging Tests: Not specified.

Data Provenance: The studies were conducted by GYN Disposables, Inc. internally or through contract labs (Steris and Nelson Laboratories for sterilization, Ethox for packaging aging). The data is prospective, as these tests are performed on the device itself as part of its development and validation. The country of origin for the data is not explicitly stated but can be inferred as the USA, where GYN Disposables, Inc. is located.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

For all tests related to biocompatibility and material performance: The "ground truth" is established by the results of the scientific tests against pre-defined regulatory standards (e.g., ISO, FDA guidelines, internal acceptance criteria). There are no "experts" in the sense of clinical reviewers establishing a ground truth based on patient cases for these engineering and biological tests. These are objective measurements rather than subjective interpretations. The testing was performed by laboratories (e.g., Nelson Laboratories for sterilization, Ethox for aging) according to established protocols.

4. Adjudication method for the test set:

Not applicable. The tests described are objective scientific and engineering measurements against pre-defined criteria, not subjective assessments requiring adjudication by multiple readers or experts.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is a manual surgical instrument, not an AI-assisted diagnostic or therapeutic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

No, a standalone algorithm performance study was not done. This device is a physical, manual instrument and does not involve any algorithms.

7. The type of ground truth used:

For Material Strength and Packaging Integrity: The ground truth is based on engineering specifications and physical test measurements (e.g., force, flexibility, burst strength, dye penetration) against pre-defined acceptance limits.
For Biocompatibility: The ground truth is based on biological responses (e.g., cell viability, temperature change, hemolysis percentage, irritation scores) observed in standardized animal and in vitro models, compared against established biological safety standards (e.g., ISO 10993 series which is referenced by the FDA's 510(k) Memorandum #G95).
For Sterilization: The ground truth is based on microbial inactivation (sterility assurance level) determined by validated methods following standards like ANSI/AAMI/ISO 11137-2:2006.

8. The sample size for the training set:

Not applicable. This device is a manual instrument, not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established:

Not applicable, as no training set was used.

Summary

{0}------------------------------------------------

510(k) Summary

Submitted By:

GYN Disposables, Inc. 2671 Appling Road Memphis, TN 38133 Tel: 901.372.6181 Fax: 901.213.0957

NOV 2 8 2007

Contact: James K. Patterson, MD, MBA

Device Classification Name: Tenaculum, Uterine

Device Name: GYN Disposables, Inc. Tenaculum 356T

Classification: 884.4530 Obstetric-gynecologic specialized manual instrument ... (15) A Uterine tenaculum is a hooklike instrument used to seize and hold the cervix or fundus.

Device Class: Class II

Classification Panel: Ob/Gyn Device Panel

Classification Product Code: HDC

Establishment Registration Number: 3006365741

Indication for Use: To snare, grasp, hold and manipulate cervical and intravaginal tissue.

Device Description: GYN Disposables Tenaculum 356T is made of glass reinforced polycarbonate. The GYN Disposable Tenaculum is supplied in a Tyvek pouch and has been sterilized by gamma radiation.

{1}------------------------------------------------

Substantial Equivalence: Atraumatic Tenacula (K930037) and Gynex Iris Hook, Gynex Angle Hook, Gynex Emmett Tenaculum (K980247) are predicate devices.

	GYN Disposables	Thomasville Medical	Gynex CorpIris HookAngle Hook
	Tenaculum 356T	Atraumatic Tenaculum	Emmett Tenaculum
510(K) Number	N/A	K930037	K980247
Product Code	HDC	HDC	HDC
Indications foruse	Snare, grasp, hold andmanipulatecervical and intravaginaltissue	Snare, grasp, hold andmanipulatecervical and intravaginaltissue	Snare, grasp, hold andmanipulatecervical and intravaginaltissue
Design	Two Tips grasp cervical andintravaginal tissueHandle with two finger holesRatcheting lock	Two Tips grasp cervical andintravaginal tissueHandle with two finger holesRatcheting lock	Single tip grasp cervical andintravaginal tissueSingle Rod
Material	Glass Reinforced Polycarbonate	302 Stainless Steel	302 Stainless Steel
Sterilization	Purchased Sterile (gamma)	Clean only	Clean only
Single use	Yes	No	No

Material Specifications: GYN Disposables Tenaculum 356T is made with glass reinforced polycarbonate. The advanced composite design can easily withstand forces during normal use as evidenced by performance testing.. In these reports non sterile, gamma sterilized non-aged, and gamma sterilized aged product were tested in four ways to determine strength and weakness in their construction. The first report determined the flexibility and the strength of the arms, the second determined the strength of the tips, and the third report determined the strength of the rack and the force needed to lock the instrument during use. The final report determined the strength of the hinge pin. All test reports showed that the instrument met the minimum acceptance criteria. These tests proved that the material does not degrade because of gamma sterilization and extended shelf life. Another test was done to determine the maximum perceived force during normal use by a physician using a stainless steel tenaculum.

Biocompatibility: The material used by GYN Disposbables, Inc. to make the subject device is a glass-reinforced polycarbonate. This material is made into an OB/GYN instrument called a Tenaculum and is gamma sterilized. The material used is classified by the Rubber And Plastic Research Association (RAPRA) as 43C12 for polycarbonate and 6272 as glass-reinforced. Even though this material or its components have been used in other medical applications and these instruments are only used once and only briefly contacts the patient, GYN Disposables has carried out seven biocompatibility tests on the as-molded, as-sterilized finished instrument.

{2}------------------------------------------------

The first test was an in vitro cytotoxicity test using the following method: the test article was put into the extraction media for not less than 24 hours. The media was incubated for 48 hours and examined for biological activity. Relative to positive and negative controls, the test article did not induce cytotoxicity.

The second test was a similar test except that the extraction was intravenously injected into rabbits. The temperatures of the rabbits were measured for up to 3 hours. This test, called a pyrogen test, in essence is a sensitization and irritation indicator for use of the instrument. These tests found that the as-made instrument did not cause any increase in temperature.

The third test was a hemolysis test. Extracts from the instrument were again made and combined with fresh, whole, rabbit blood using a process that takes approximately 2 hours. The average % hemolysis was determined to be 0.0%, meaning that the extract did not cause damage to blood cells.

In addition to these three tests, four in vivo tests of toxicity were also performed-dermal sensitization in a guinea pig, systemic toxicity in a mouse, and two types of irritation testing (one intracutaneous [between the layers of the skin] and one vaginal) both in rabbits. In all four tests the GYN material passed. Duration of contact of tissue for cytotoxicity, and systemic toxicity was 24, 48, and 72 hours. Contact for Intercutaneous irritation test was 72 hours, vaginal irritation 24 hours for five consecutive days, and systemic toxicity for 1, 1.5, 2, 2.5, and 3 hours.

These seven tests meet and exceed the criteria established in Table 1 in the FDA's 510(k) Memorandum #G95 (dated May 1, 1995) as follows. The disposable Tenaculum instrument has minimal contact duration with the patient and therefore meets Category A (<24hours). It also can worse case be considered an "External Communicating Device" since it is used in the cervix and it also worse case can be considered a "Blood Path, Indirect" product since the cervix is often a bloody field during OB/GYN surgery. According to Table 1, these criteria require cytotoxicity, sensitization, system toxicity (acute), and hemocompatibility testing. The testing provided are sufficient to assure the passage of the toxicology testing for this device for the brief and one-time intended use. These tests confirm that the manufacturing and sterilization procedures used by GYN do not affect the underlying biocompatibility of the material used.

Sterilization: Product will be sold sterile using gamma radiation. Sterilization validation was performed by Steris in conjunction with Nelson Laboratories. This report follows the ANSI/AAMI/ISO 1137-2:2006 guidelines to perform product qualification for irradiation sterilization of a health care product. Initial verification dosing, bioburden, bacteriostasis/fungistis, and sterility testing were done and acceptance criteria were met. Accelerated aging validation for one year shelf life has been performed by Ethox using sterilized samples. The product packaging met the requirements of the burst test at the non-aged and 1 yr accelerated aged time point. Product packaging met the requirements of the dye penetration test both non-aged and 1 yr aged.

{3}------------------------------------------------

Packaging: Tyvek

and the comments of the comments of the comments of the comments of

and the contraction of the comments of the comments of the comments of

{4}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized eagle emblem with three parallel lines forming the body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 8 2007

GYN Disposables, Inc. c/o Mr. Robert Mosenkis President CITECH Medical Device Testing and Consulting 5200 Butler Pike PLYMOUTH MEETING PA 19462-1298

Re: K073182

Trade/Device Name: GYN Disposables Tenaculum 356T Regulation Number: 21 CFR §884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulatory Class: II Product Code: HDC Dated: November 12, 2007 Received: November 13, 2007

Dear Mr. Mosenkis:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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 (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{5}------------------------------------------------

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C Brogdon

Nancy C. B rogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

Indications for Use

K013182 510(k) Number (if known):

Device Name: GYN Disposables Tenaculum 356T

Indications For Use: Snare, grasp, hold and manipulate cervical and intravaginal tissue.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hebert Lewis

(Division Sign-Off) Division of Reproductive, Abdominal and Radlological Devices 510(k) Number

Page 1 of 1

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.