K060573 · Vascular Control Systems, Inc. · HDC · Apr 21, 2006 · Obstetrics/Gynecology
Device Facts
Record ID
K060573
Device Name
BURBANK TENACULUM
Applicant
Vascular Control Systems, Inc.
Product Code
HDC · Obstetrics/Gynecology
Decision Date
Apr 21, 2006
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 884.4530
Device Class
Class 2
Attributes
Therapeutic, 3rd-Party Reviewed
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.
Device Story
Burbank Tenaculum is a manual, ring-handled surgical instrument; features distal tooth for seizing/holding cervix; includes guiderod for guiding/securing Vascular Control Systems flostat Clamp; incorporates uterine sound for insertion through cervical opening into uterine cavity. Used by surgeons in clinical settings during gynecologic procedures; facilitates placement of Doppler-guided clamps for uterine artery control. Device provides mechanical stability for clamp positioning; assists in temporary hemorrhage control during surgery.
Clinical Evidence
Bench testing only. Device designed and tested per internal design control procedures; met all product specifications.
Technological Characteristics
Manual surgical instrument; ring-handled with ratchet closure; distal tooth for tissue grasping; guiderod for clamp securement; uterine sound component. Materials include glass-filled nylon. Non-powered, mechanical device.
Indications for Use
Indicated for use in patients undergoing conservative gynecologic surgery, such as laparoscopic myomectomy, requiring bilateral uterine artery detection and temporary bleeding control. Used in conjunction with flostat Clamp and Transvaginal Doppler Probe.
Regulatory Classification
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.
Special Controls
*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.
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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.<br>32236-F Paseo Adelanto<br>San Juan Capistrano, CA 92675<br>(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.
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### 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.
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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.
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Protecting and Promoting Public Health
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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
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## 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
Page 1 of
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
