The Burbank Tenaculum is an accessory used in conjunction with the Vascular Control Systems Transvaginal Doppler Probe. The device is intended to seize and hold the cervix and to hold and secure the Transvaginal Doppler Probe in place, while performing audible Doppler procedures.

Device Description

The Burbank Tenaculum is a stainless steel, ring-handled instrument with a hook at the distal end of one arm and a guide rod attached to the distal end of the other arm. The proximal end of the guide rod is threaded to guide insertion of the Vascular Control Systems Transvaginal Doppler Probe (TDP) into the vagina and secure the TDP in place. A uterine sound is brazed at the distal end of the guide rod intended to be inserted through the cervical opening into the uterine cavity.

AI/ML Overview

The provided text describes a medical device, the Burbank Tenaculum, seeking 510(k) clearance. This means it is claiming substantial equivalence to legally marketed predicate devices, rather than establishing entirely new performance criteria through extensive clinical trials. Therefore, the information typically associated with acceptance criteria and a study to prove they are met (like a multi-reader multi-case study, detailed ground truth establishment, or specific performance metrics with statistical analysis) is not present in this document.

Instead, the document focuses on demonstrating that the Burbank Tenaculum is as safe and effective as its predicate devices based on design similarities and intended use.

Here's an analysis based on the information provided, specifically addressing your points where possible:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of explicit, quantifiable acceptance criteria or reported device performance in the manner one might expect for a new, higher-risk device. The clearance is based on substantial equivalence to predicate devices. The "reported device performance" is essentially the qualitative claim that it meets its product specifications and does not raise new safety or effectiveness issues, similar to already marketed devices.

Acceptance Criteria (Implied)	Reported Device Performance
Functions as an accessory for Transvaginal Doppler Probe	Intended to seize/hold cervix and secure TDP in place for Doppler procedures
Similar design/materials to predicate devices	Stainless steel, ring-handled, hook, guide rod, uterine sound. Materials similar to predicates.
Does not raise new safety/effectiveness issues	"Found to meet its product specifications." "Does not raise new issues of safety, effectiveness, or performance."
Capable of seizing and holding the cervix	Designed with a hook for seizing and holding the cervix, ratchet closure
Capable of securing an ultrasound device	Equipped with a mechanism to hold an ultrasound device
Uterine sound component is substantially equivalent in design and materials	Uterine sound is substantially equivalent in design and materials as the Sims Uterine Sound.
Provided non-sterile and reusable	Provided non-sterile, and reusable

2. Sample size used for the test set and the data provenance

No test set sample size or data provenance is mentioned. The clearance is based on design and material comparisons to predicate devices, and internal design control procedures.

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

Not applicable. No ground truth was established by experts for a test set in the context of this 510(k) submission.

4. Adjudication method for the test set

Not applicable. No test set requiring adjudication was used.

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

Not applicable. This is a medical instrument (tenaculum), not an AI device or imaging analysis tool. No MRMC study was performed.

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

Not applicable. This is a manual surgical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The concept of "ground truth" as it applies to diagnostic or AI devices is not relevant here. The ground for substantial equivalence is the design, materials, intended use, and functioning characteristics comparison to existing, legally marketed predicate devices, and the claim that it meets its own product specifications.

8. The sample size for the training set

Not applicable. As a physical instrument, there is no "training set" in the machine learning sense. The "training" essentially comes from engineering design, material selection, and manufacturing processes, guided by existing device standards and performance of predicates.

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

Not applicable. There is no training set mentioned. The "ground truth" for its design and manufacturing would be established through engineering specifications, material properties, and adherence to quality systems and design controls (as mentioned: "The Burbank Tenaculum has been designed and tested per design control procedures and was found to meet its product specifications and does not raise new issues of safety, effectiveness, or performance of the product.").

Summary

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SUMMARY OF SAFETY AND EFFECTIVENESS JAN 2 4 2003

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of the SMDA and 21 CFR 807.92.

1. Submitter's name, address, telephone number, contact person, and date summary prepared:

a.	Submitter:	Vascular Control Systems, Inc.32236-E Paseo AdelantoSan Juan Capistrano, CA 92675(949) 488-8700
b.	Contact Person:	Al MemmoloVice President, Regulatory Affairs/Quality Assurance(949) 488-8700 ext. 108
c.	Date Summary Prepared:	December 12, 2002

Name of device, including trade name and classification name:

a.	Trade/Proprietary Name:	Burbank Tenaculum
b.	Classification name:	Uterine Tenaculum (21 CFR §884.4530)

3. Identification of the predicate device or legally marketed device or devices to which substantial equivalence is being claimed:

A. Company:	Ron-Tech Medical Ltd..
Device:	Transvaginal Ultrasound Probe Holder Device
510(k):	K992071
Date Cleared:	August 27, 1999
B. Company:	Gilbert Surgical Instruments

Company:	Gilbert Surgical Instruments
Device:	Sims Uterine Sound
510(k):	N/A (The Uterine Sound is a Class I device which is 510(k) Exempt)

A description of the device that is the subject of the 510(k), including explanation of 4. how the device functions, basic scientific concepts, significant physical and performance characteristics (design, material, physical properties):
The Burbank Tenaculum is a stainless steel, ring-handled instrument with a hook at the distal end of one arm and a guide rod attached to the distal end of the other arm. The proximal end of the guide rod is threaded to guide insertion of the Vascular Control Systems Transvaginal Doppler Probe (TDP) into the vagina and secure the TDP in place.

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A uterine sound is brazed at the distal end of the guide rod intended to be inserted through the cervical opening into the uterine cavity.

ડ. Statement of intended use:

The Burbank Tenaculum is an accessory used in conjunction with the Vascular Control Systems Transvaginal Doppler Probe. The device is intended to seize and hold the cervix and secure the Transvaginal Doppler Probe in place, while performing audible Doppler procedures.

Statement of how the technological characteristics of the device compare to those of ર્. the predicate or legally marketed device.

Like the predicate Transvaginal Ultrasound Probe Holder Device, the Burbank Tenaculum is a ring-handled device with ratchet closure for seizing and holding the cervix. Also like the Transvaginal Ultrasound Probe Holder Device, the Burbank Tenaculum is designed with a hook for seizing and holding the cervix and is equipped with a mechanism to hold an ultrasound device. The Burbank Tenaculum also has a uterine sound which is substantially equivalent in design and materials as the Sims Uterine Sound. The materials used in the Burbank Tenaculum are similar to those of the predicate devices and are provided non-sterile, and reusable.

7. Brief summary of nonclinical tests and results:

The Burbank Tenaculum has been designed and tested per design control procedures and was found to meet its product specifications. The Burbank Tenaculum does not raise new issues of safety, effectiveness, or performance of the product.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

JAN 2 4 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Vascular Control Systems, Inc. % Mr. Heinz Joerg Steneberg TÜV Rheinland of North America 12 Commerce Road NEWTON CT 06470

Re: K030078

Trade/Device Name: Burbank Tenaculum and Transvaginal Ultrasound Probe Holder Regulation Number: 21 CFR 884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 85 HDC Product Code: 90 ITX Dated: January 6, 2003 Received: January 9, 2003

Dear Mr. Steneberg:

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 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.

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.

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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 Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

8xx. 1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely vours.

Nancy C. Brogdon

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

Enclosure

Page 2

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Indications for Use Statement

510(k) Number (if known): K030078

Page 1 of 1

Device Name:

Burbank Tenaculum

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109)

Over-The-Counter-Use

David A. Symm

020078 510(k) Nur

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.