(46 days)
Not Found
No
The device description and intended use describe a purely mechanical instrument used to hold and secure other devices. There is no mention of any computational or algorithmic processing, let alone AI/ML.
No.
The device is used to seize and hold the cervix and to hold and secure a clamp during surgical procedures, and is explicitly described as an accessory. It does not exert its effect through pharmacological, immunological, or metabolic means, nor does it achieve its primary intended purposes through chemical action within or on the body. Instead, it is a mechanical instrument used to facilitate a surgical procedure.
No
The device is an accessory used to seize and hold the cervix and secure a clamp during audible Doppler procedures. It is a surgical instrument for manipulation and temporary control, not for the purpose of identifying a medical condition or disease.
No
The device description clearly describes a physical, ring-handled instrument with a tooth and guiderod, indicating it is a hardware device, not software.
Based on the provided information, the Burbank Tenaculum is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Burbank Tenaculum's Function: The description clearly states the Burbank Tenaculum is an accessory used in conjunction with a clamp and Doppler probe. Its function is to physically seize and hold the cervix, guide and secure a clamp, and potentially measure uterine depth with a uterine sound.
- No Sample Analysis: The device does not analyze any biological samples taken from the patient. It is a surgical instrument used for manipulation and positioning during a procedure.
- Procedure-Based Use: Its use is directly tied to an audible Doppler procedure and conservative gynecologic surgery.
Therefore, the Burbank Tenaculum falls under the category of a surgical instrument or accessory, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Burbank Tenaculum is an accessory used in conjunction with Vascular Control Systems' flostat™ Clamp. The device is intended to seize and hold the cervix and secure the flostat Clamp in place, during audible Doppler procedures.
This Tenaculum is only indicated for use with the flostat Clamp and Transvaginal Doppler Probe for bilateral uterine artery detection and temporary control of bleeding during conservative gynecologic surgery such as laparoscopic myomectomy.
Product codes
HDC, DXC
Device Description
The Burbank Tenaculum is a ring-handled instrument with a tooth at the distal end of one arm and a guiderod attached to the distal end of the other arm. The proximal end of the guiderod is threaded to guide insertion of the Vascular Control Systems flostat Clamp into the vagina and secure the Clamp in place.
A uterine sound, at the distal end of the guiderod, is intended for insertion through the cervical opening into the uterine cavity.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Doppler
Anatomical Site
cervix, uterine cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows a sequence of handwritten characters and numbers. The sequence starts with the letters 'Kd', followed by the number '0', then the number '5', the number '7', and ends with the number '3'. The characters and numbers are written in a dark ink, and the background is white.
SUMMARY OF SAFETY AND EFFECTIVENESS
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.
- Submitter's name, address, telephone number, contact person, and date 1. summary prepared:
| a. | Submitter: | Vascular Control Systems, Inc.
32236-F Paseo Adelanto
San Juan Capistrano, CA 92675
(949) 488-8700 |
|----|-----------------|-------------------------------------------------------------------------------------------------------------|
| b. | Contact Person: | Kathleen Roberts |
- Contact Person: Kathleen Roberts b. RA/QA Manager (949) 488-8700 ext. 115
- April 5, 2006 Date Summary Prepared: C.
- Name of device, including trade name and classification name: 2.
| a. | Trade/Proprietary Name: | Burbank Tenaculum |
|---|---|---|
| b. | Classification name: | Uterine Tenaculum (21 CFR §884.4530) |
- Identification of the predicate device or legally marketed device or devices to 3. which substantial equivalence is being claimed:
| Company: | Vascular Control Systems, Inc. |
|---|---|
| Device: | Burbank Tenaculum |
| 510(k): | K030078 |
| Date Cleared: | January 24, 2003 |
- A description of the device that is the subject of the 510(k), including explanation 4. of how the device functions, basic scientific concepts, significant physical and performance characteristics (design, material, physical properties):
The Burbank Tenaculum is a ring-handled instrument with a tooth at the distal end of one arm and a guiderod attached to the distal end of the other arm. The proximal end of the guiderod is threaded to guide insertion of the Vascular Control Systems flostat Clamp into the vagina and secure the Clamp in place.
A uterine sound, at the distal end of the guiderod, is intended for insertion through the cervical opening into the uterine cavity.
1
ನ. Statement of intended use:
The Burbank Tenaculum is an accessory used in conjunction with Vascular Control Systems' flostat™ Clamp. The device is intended to seize and hold the cervix and secure the flostat Clamp in place, during audible Doppler procedures.
This Tenaculum is only indicated for use with the flostat Clamp and Transvaginal Doppler Probe for bilateral uterine artery detection and temporary control of bleeding during conservative gynecologic surgery such as laparoscopic myomectomy.
Statement of how the technological characteristics of the device compare to those 6. of the predicate or legally marketed device.
Both devices are ring-handled with ratchet closure for seizing and holding the cervix. Both devices are designed with a tooth for seizing and holding the cervix and are equipped with a mechanism to hold an ultrasound guided clamp. The new materials used in the modified Burbank Tenaculum include glass-filled nylon not part of the original design.
Brief summary of nonclinical tests and results: 7.
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.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the caduceus.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
APR 2 1 2006
Vascular Control Systems, Inc. % Mr. Tamas Borsai Program Manager, Third Party Review Program TÜV Rheinland of North America 12 Commerce Road NEWTON CT 06470
Re: K060573
Trade/Device Name: Burbank Tenaculum Regulation Number: 21 CFR §884.4530 Regulation Name: Obstetric-gynecology specialized manual instrument Product Code: HDC Regulation Number: 21 CFR §870.4450 Regulation Name: Vascular Clamp Product Code: DXC Regulatory Class: II Dated: April 6, 2006 Received: April 7, 2006
Dear Mr. Borsai:
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 prodicate 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 (Premarket Approval), 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.
Image /page/2/Picture/10 description: The image shows a circular logo with the text "1906 - 2006" at the top. The letters "FDA" are prominently displayed in the center of the logo. Below the letters, the word "Centennial" is written. There are three stars at the bottom of the logo.
Protecting and Promoting Public Health
3
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 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" (21 CFR 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
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
4
INDICATIONS FOR USE
510(k) Number (if known): K060573
Device Name: Burbank Tenaculum
Indications for Use:
The Burbank Tenaculum is an accessory used in conjunction with the Vascular Control Systems flostat™ Clamp. The device is intended to seize and hold the cervix and to hold and secure the flostat Clamp in place, during audible Doppler procedures.
This Tenaculum is only indicated for use with the flostat Clamp and Transvaginal Doppler Probe for bilateral uterine artery detection and temporary control of bleeding during conservative gynecologic surgery such as laparoscopic myomectomy.
Prescription Use × (Per 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)
Harley C. Herndon
(Division Sign-Off) Division of Reproductive, Abdominal. and Radiological Device 510(k) Number
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