K203820 · Aspivix SA · HDC · Aug 17, 2021 · Obstetrics/Gynecology
Device Facts
Record ID
K203820
Device Name
ASPIVIX v1.1 Cervical Suction Tenaculum
Applicant
Aspivix SA
Product Code
HDC · Obstetrics/Gynecology
Decision Date
Aug 17, 2021
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 884.4530
Device Class
Class 2
Indications for Use
The ASPIVIX v1.1 Cervical Suction Tenaculum is indicated to snare, grasp, hold and manipulate cervical tissue.
Device Story
ASPIVIX v1.1 is a sterile, single-use, manual gynecological instrument designed to replace traditional mechanical tenacula. It utilizes a vacuum-based mechanism to grasp cervical tissue rather than piercing it with sharp tips. The device consists of a main body with an embedded reloadable vacuum reserve, an activation/deactivation slider ring, a sliding tube to generate suction, and an anatomic suction pad that contacts the cervix. Operated by a healthcare professional in a clinical setting, the device is held with one hand. By sliding the tube, the user creates a vacuum at the suction pad, allowing the device to snare and hold the cervix for manipulation during procedures. This non-traumatic suction approach aims to reduce patient discomfort and tissue trauma compared to traditional ratcheting tenacula that use sharp teeth.
Clinical Evidence
Bench testing only. No clinical data provided. Performance testing included release traction force, mechanical traction (pull), bend strength, and tissue safety. Biocompatibility testing (cytotoxicity, sensitization, vaginal irritation) per ISO 10993-1 confirmed the device is non-cytotoxic, non-sensitizing, and non-irritating.
Indicated for snaring, grasping, holding, and manipulating cervical tissue in patients undergoing gynecological procedures.
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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September 3, 2021
Aspivix S.A. Julien FINCI CTO & Co-founder Chemin du Closel 5 Renens, Renens 1020 SWITZERLAND
Re: K203820
> Trade/Device Name: ASPIVIX v1.1 Cervical Suction Tenaculum Regulation Number: 21 CFR 884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulatory Class: II Product Code: HDC
Dear Julien FINCI:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated 8/17/21. Specifically, FDA is updating this SE Letter to correct the contact's name as an administrative correction. The issued letter did not reflect the change in contact person that occurred during the agency review.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Jason Roberts, OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices, (240) 402-6400. Jason.Roberts@fda.hhs.gov.
Sincerely,
Jason Roberts -S
Jason R. Roberts, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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August 17, 2021
Aspivix S.A. Benjamin Klein Regulatory Affairs and Quality Manager Chemin du Closel Renens. Renens 1020 Switzerland
Re: K203820
> Trade/Device Name: ASPIVIX v1.1 Cervical Suction Tenaculum Regulation Number: 21 CFR§ 884.4530 Regulation Name: Obstetric-Gynecologic Specialized Manual Instrument Regulatory Class: II Product Code: HDC Dated: June 28, 2021 Received: July 13, 2021
Dear Benjamin Klein:
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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jason Roberts -S
Jason R. Roberts, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number (if known) K203820
Device Name ASPIVIX v1.1 Cervical Suction Tenaculum
Indications for Use (Describe)
The ASPIVIX v1.1 Cervical Suction Tenaculum is indicated to snare, grasp, hold and manipulate cervical tissue.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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## 510(k) SUMMARY
| Submitter: | ASPIVIX SA |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Chemin du Closel 5 |
| | 1020 Renens |
| | Switzerland |
| Contact Person: | Julien FINCI, |
| | Regulatory Affairs & Quality Manager |
| | Telephone: +41 (0) 76 327 87 97 |
| | E-mail: julien.finci@aspivix.com |
| Date Prepared: | August 10, 2021 |
| Name of Device: | ASPIVIX v1.1 Cervical Suction Tenaculum |
| Common Name: | Cervical Tenaculum |
| Device Class: | Class II |
| Regulation Name &<br>Number: | 21 CFR 884.4530 - Obstetric-gynecologic specialized manual<br>instrument |
| Predicate Device: | K073182 - GYN Disposables INC Tenaculum 356T |
| | The predicate device has not been subject to a design-related recall. |
| Product Code: | HDC, Tenaculum, Uterine |
| Reference Device: | Bioceptive Suction Cervical Retractor (K142204) |
| Description of Device: | ASPIVIX v1.1 is a sterile, single-use, one-piece device that consists<br>of four non-removable parts: a reloadable vacuum reserve embedded<br>inside the main body, an activation / deactivation slider ring, a sliding<br>tube to generate vacuum in the main body and an anatomic suction<br>pad to put in contact with the cervix. |
| Indication for Use: | ASPIVIX v1.1 Cervical Suction Tenaculum is indicated to snare,<br>grasp, hold and manipulate cervical tissue. |
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| Comparison of<br>Technological<br>Characteristics with<br>the Predicate<br>Device: | ASPIVIX v1.1 | Tenaculum 356T<br>(Predicate) |
|------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| 510(k) number | K203820 | K073182 |
| Product Code | HDC | HDC |
| Indication for Use | The ASPIVIX v1.1 Cervical Suction<br>Tenaculum is indicated to snare,<br>grasp, hold and manipulate cervical<br>tissue | Snare, grasp, hold and<br>manipulate cervical and<br>intravaginal tissue |
| Design | Suction pad grasps cervical tissue<br>trough vacuum.<br>Handle with one hand.<br>Sliding lock. | Two Tips grasp cervical and<br>intravaginal tissue.<br>Handle with two finger holes.<br>Ratcheting lock. |
| Material | Polycarbonate/Polyester,<br>thermoplastic elastomer, Mixture of<br>methacrylic acid esters and<br>photoinitiator, Polypropylene like<br>material and Triethyl O-acetylcitrate | Glass Reinforced Polycarbonate |
| Use Environment | Healthcare professional in a<br>healthcare facility | Healthcare professional in a<br>healthcare facility |
| Sterilization | Yes | Yes |
| Single use | Yes | Yes |
| | The differences in technological characteristics do not raise different<br>questions of safety and effectiveness. | |
| Indications for Use<br>Comparison | The subject and predicate device have the same intended use to snare,<br>grasp, hold, and manipulate cervical tissue. | |
| Performance Data: | The following performance data were provided in support of substantial<br>equivalence. | |
| | <b>Biocompatibility testing</b> | |
| | The biocompatibility evaluation for ASPIVIX v1.1 was conducted in<br>accordance with the FDA guidance "Use of International Standard ISO<br>10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and<br>testing within a risk management process". Testing included: | |
| | ● Cytotoxicity (ISO 10993-5:2009)<br>● Sensitization ((ISO 10993-10:2010) | |
| | • Vaginal Irritation (ISO 10993-10:2010) | |
| | The results of testing demonstrated the subject device is non-cytotoxic,<br>non-sensitizing, and non-irritating. | |
| | <b>Sterilization</b> | |
| | The device is provided sterile via irradiation by e-beam. Sterilization<br>validation was performed in accordance with methods equivalent to<br>ANSI/AAMI/ISO 11137-2: 2013. | |
| | <b>Performance Testing</b> | |
| | Testing was performed in order to assess the performance and safety of<br>ASPIVIX v1.1 according to the requirements specified in its designs and<br>user specifications. All test results were in accordance with the test<br>acceptance criteria. Testing included release traction force, mechanical<br>traction (pull), bend strength, and tissue safety. | |
| Conclusion: | The results of performance testing described above demonstrate that the<br>ASPIVIX v1.1 is as safe and effective as the predicate device and supports<br>a determination of substantial equivalence. | |
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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.
