(231 days)
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML or data-driven analysis.
No
The device is described as a surgical instrument specifically designed to "snare, grasp, hold and manipulate cervical tissue" during procedures, not to treat a disease or condition.
No
The device description and intended use indicate that the ASPIVIX v1.1 is used to "snare, grasp, hold and manipulate cervical tissue," which are actions related to physical manipulation during a procedure, not diagnosis. There is no mention of it collecting data or providing information about a patient's medical condition.
No
The device description clearly outlines a physical, single-use medical device with mechanical components (vacuum reserve, slider ring, sliding tube, suction pad) designed to physically interact with cervical tissue. It is not software-only.
Based on the provided information, the ASPIVIX v1.1 Cervical Suction Tenaculum is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "snare, grasp, hold and manipulate cervical tissue." This describes a physical manipulation of tissue within the body, not a test performed on samples taken from the body.
- Device Description: The device description details a physical tool with mechanical components for applying suction and holding tissue. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Reagents or assays
- Measurement of analytes in biological samples (blood, urine, tissue samples, etc.)
- Diagnostic interpretation of results from sample analysis
The device is clearly a surgical/gynecological instrument used for physical manipulation of tissue during a procedure.
N/A
Intended Use / Indications for Use
The ASPIVIX v1.1 Cervical Suction Tenaculum is indicated to snare, grasp, hold and manipulate cervical tissue.
Product codes
HDC
Device Description
ASPIVIX v1.1 is a sterile, single-use, one-piece device that consists of four non-removable parts: a reloadable vacuum reserve embedded inside the main body, an activation / deactivation slider ring, a sliding tube to generate vacuum in the main body and an anatomic suction pad to put in contact with the cervix.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical tissue, intravaginal tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare professional in a healthcare facility
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility testing:
The biocompatibility evaluation for ASPIVIX v1.1 was conducted in accordance with the FDA guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". Testing included:
Cytotoxicity (ISO 10993-5:2009)
Sensitization ((ISO 10993-10:2010)
Vaginal Irritation (ISO 10993-10:2010)
The results of testing demonstrated the subject device is non-cytotoxic, non-sensitizing, and non-irritating.
Sterilization:
The device is provided sterile via irradiation by e-beam. Sterilization validation was performed in accordance with methods equivalent to ANSI/AAMI/ISO 11137-2: 2013.
Performance Testing:
Testing was performed in order to assess the performance and safety of ASPIVIX v1.1 according to the requirements specified in its designs and user specifications. All test results were in accordance with the test acceptance criteria. Testing included release traction force, mechanical traction (pull), bend strength, and tissue safety.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
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Image /page/0/Picture/0 description: The image shows the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
Image /page/1/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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.
2
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 & | |
| Number: | 21 CFR 884.4530 - Obstetric-gynecologic specialized manual |
| 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 |
| of four non-removable parts: a reloadable vacuum reserve embedded | |
| inside the main body, an activation / deactivation slider ring, a sliding | |
| tube to generate vacuum in the main body and an anatomic suction | |
| pad to put in contact with the cervix. | |
| Indication for Use: | ASPIVIX v1.1 Cervical Suction Tenaculum is indicated to snare, |
| grasp, hold and manipulate cervical tissue. |
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| Comparison of
Technological
Characteristics with
the Predicate
Device: | ASPIVIX v1.1 | Tenaculum 356T
(Predicate) |
|------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| 510(k) number | K203820 | K073182 |
| Product Code | HDC | HDC |
| Indication for Use | The ASPIVIX v1.1 Cervical Suction
Tenaculum is indicated to snare,
grasp, hold and manipulate cervical
tissue | Snare, grasp, hold and
manipulate cervical and
intravaginal tissue |
| Design | Suction pad grasps cervical tissue
trough vacuum.
Handle with one hand.
Sliding lock. | Two Tips grasp cervical and
intravaginal tissue.
Handle with two finger holes.
Ratcheting lock. |
| Material | Polycarbonate/Polyester,
thermoplastic elastomer, Mixture of
methacrylic acid esters and
photoinitiator, Polypropylene like
material and Triethyl O-acetylcitrate | Glass Reinforced Polycarbonate |
| Use Environment | Healthcare professional in a
healthcare facility | Healthcare professional in a
healthcare facility |
| Sterilization | Yes | Yes |
| Single use | Yes | Yes |
| | The differences in technological characteristics do not raise different
questions of safety and effectiveness. | |
| Indications for Use
Comparison | The subject and predicate device have the same intended use to snare,
grasp, hold, and manipulate cervical tissue. | |
| Performance Data: | The following performance data were provided in support of substantial
equivalence. | |
| | Biocompatibility testing | |
| | The biocompatibility evaluation for ASPIVIX v1.1 was conducted in
accordance with the FDA guidance "Use of International Standard ISO
10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and
testing within a risk management process". Testing included: | |
| | ● Cytotoxicity (ISO 10993-5:2009)
● Sensitization ((ISO 10993-10:2010) | |
| | • Vaginal Irritation (ISO 10993-10:2010) | |
| | The results of testing demonstrated the subject device is non-cytotoxic,
non-sensitizing, and non-irritating. | |
| | Sterilization | |
| | The device is provided sterile via irradiation by e-beam. Sterilization
validation was performed in accordance with methods equivalent to
ANSI/AAMI/ISO 11137-2: 2013. | |
| | Performance Testing | |
| | Testing was performed in order to assess the performance and safety of
ASPIVIX v1.1 according to the requirements specified in its designs and
user specifications. All test results were in accordance with the test
acceptance criteria. Testing included release traction force, mechanical
traction (pull), bend strength, and tissue safety. | |
| Conclusion: | The results of performance testing described above demonstrate that the
ASPIVIX v1.1 is as safe and effective as the predicate device and supports
a determination of substantial equivalence. | |
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