JARIT® Hulka Uterine Tenaculum Forceps are indicated to stabilize the cervix and manipulate the uterine fundus under direct pelviscopic visualization in women whose uteri are anteverted or retroverted.

Device Description

JARIT Hulka Uterine Tenaculum Forceps are an 11-inch long stainless steel, ring-handled instrument with ratchet closure having a single-tooth hook at the distal end of one arm and a 3.6 mm diameter uterine sound probe at the distal end of the other arm. The device is reusable, sterilizable and packaged non-sterile.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called JARIT® Hulka Uterine Tenaculum Forceps. This type of filing is for demonstrating substantial equivalence to a predicate device, not for proving the device meets specific acceptance criteria through a clinical study. Therefore, the information requested in your prompt regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not applicable to this document, as these types of studies are typically required for premarket approval (PMA) applications or de novo classifications, not 510(k) clearances for devices like this.

The document states: "The JARIT Hulka Uterine Tenaculum Forceps are substantially equivalent to the legally marketed predicate devices. The devices have the same intended use, design, materials and processing." This statement, along with the device description, serves as the basis for clearance.

To directly answer your questions based on the provided text:

A table of acceptance criteria and the reported device performance
- N/A. The document does not describe acceptance criteria in the context of a performance study. Its equivalence is based on "same intended use, design, materials and processing" as predicate devices.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- N/A. No test set or data provenance is mentioned as part of a performance study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- N/A. No experts or ground truth establishment are part of this 510(k) submission.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. No adjudication method is mentioned.
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
- N/A. The device is a manual surgical instrument, not an AI-assisted diagnostic tool. No MRMC study or AI component is relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. Not applicable, as this is a physical, manual instrument.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- N/A. No ground truth is mentioned.
The sample size for the training set
- N/A. No training set is mentioned.
How the ground truth for the training set was established
- N/A. No training set or ground truth establishment is mentioned.

In summary, the provided document is a 510(k) clearance based on substantial equivalence, and therefore does not contain the information you requested about acceptance criteria, study data, or ground truth pertaining to device performance studies.

Summary

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KOr2345

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NOV 21 2008

510(k) Summary

Submitted by:	J. Jamner Surgical Instruments, Inc.9 Skyline DriveHawthorne, NY 10532
Contact Person:	Jennifer Bosley, Regulatory Affairs ManagerIntegra Medical Instrument GroupC/o Miltex, Inc.589 Davies Drive, York, PA 17402 USAPhone: (717) 781-6392Fax: (717) 840-3509
Date Prepared:	October 2, 2008
510(k) Number:	K082349
Device Trade Name:	JARIT® Hulka Uterine Tenaculum Forceps
Common/Usual Name:	Uterine Tenaculum
Proposed Classification:	Obstetric-gynecologic specialized manual instrument21CFR§884.4530(a)(15) Class II, 85HDC

Device Description:

Indications for Use:

JARIT Huika Uterine Tenaculum Forceps are indicated to stabilize the cervix and manipulate the uterine fundus under direct pelviscopic visualization in women whose uteri are anteverted or retroverted.

Predicate Devices:

510(k) #	Device	Manufacturer
Preamendment	JARIT Braun Uterine Tenaculum Forceps	J. Jamner Surgical Instruments
Preamendment	Hulka Tenaculum	Pilling Weck Surgical

Substantial Equivalence:

The JARIT Hulka Uterine Tenaculum Forceps are substantially equivalent to the legally marketed predicate devices. The devices have the same intended use, design, materials and processing.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 1 2008

Ms. Jennifer Bosley Regulatory Affairs Manager Integra Medical Instrument Group - Miltex J. Jamner Surgical Instruments, Inc. 9 Skyline Drive HAWTHORNE NY 10532

K082349 Re:

Trade/Device Name: JARIT® Hulka Uterine Tenaculum Forceps Regulation Number: 21 CFR §884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulatory Class: II Product Code: HDC Dated: October 2, 2008 Received: October 3, 2008

Dear Ms. Boslev:

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, l'isting 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.

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Page 2

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 agencics. 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 dcsire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(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 Biometrics' (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/odrh/industry/support/index.html.

Sincerely yours.

Jorgu M. Whang

Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications For Use

510(k) Number: K082349

Device Name: JARIT® Hulka Uterine Tenaculum Forceps

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter-Use (Part 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)

Division Sign-Off)
Division of Reproductive, Abdominal,

Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K082349

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.