Carevix™ Suction Cervical Stabilizer is a sterile, single-use, two-piece device consisting of three main parts: a reloadable vacuum reserve embedded inside the main body, including a piston to generate the vacuum, an activation/deactivation push-button, and an anatomic-shaped suction head to put in contact with the cervix. The suction head includes a rod that connects the main body.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Carevix™ Suction Cervical Stabilizer. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a full study report for a novel medical device, especially an AI/ML-driven one.

Therefore, many of the requested details, particularly those pertaining to AI/ML device performance (sample size for test set, data provenance, number of experts for ground truth, adjudication, MRMC studies, standalone performance, training set details), are not present in the provided text, as this is a traditional medical device submission.

Here's what can be extracted based on the provided text:

Acceptance Criteria and Device Performance:

The document states that the device was evaluated against its design and user specifications, and that "All the results were in accordance with the test acceptance criteria." However, it does not provide a table of specific quantitative acceptance criteria or the reported device performance metrics for different parameters (e.g., specific force applied, vacuum pressure achieved, or a pass/fail rate for a clinical outcome).

Instead, it lists the types of tests performed and their general outcomes:

Test Category	Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility	Non-cytotoxic, non-sensitizing, non-irritating	"demonstrated the subject device is non-cytotoxic non-sensitizing, and non-irritating."
Sterilization	Meets ANSI/AAMI/ISO 11137-2:2013 standards	"Sterilization validation was performed... and was conducted following testing protocols used for the predicate device." (Implied successful validation)
Performance & Safety	Meets design and user specifications, no new safety/effectiveness questions raised compared to predicate.	"All tests were conducted according to the protocols used to validate the predicate device ASPIVIX v1.1. All the results were in accordance with the test acceptance criteria."

Missing Information (as per the provided text):

Sample size used for the test set and the data provenance: Not mentioned. The testing appears to be primarily bench testing (biocompatibility, sterilization, performance) rather than clinical studies with patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not mentioned. Ground truth as typically understood for AI/ML devices (e.g., disease presence) is not relevant to this device's testing.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/not mentioned.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is not an AI/ML device nor a diagnostic imaging device that would typically involve human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, as this is not an AI/ML algorithm.
The type of ground truth used: For biocompatibility, the ground truth is established by standardized lab tests (e.g., cell viability, skin irritation). For performance, the ground truth is the device's design specifications. No "expert consensus" or "pathology" ground truth is mentioned.
The sample size for the training set: Not applicable, as this is not an AI/ML device.
How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

Summary of what the document focuses on instead:

The document outlines a 510(k) submission for a modified medical device. The primary goal is to demonstrate "substantial equivalence" to a previously cleared predicate device (ASPIVIX v1.1 Cervical Suction Tenaculum, K203820). This is achieved by:

Comparing Indications for Use: Stating they are the same ("to snare, grasp, hold and manipulate cervical tissue").
Comparing Technological Characteristics: Identifying both similarities and differences (e.g., changes in rod length, inner diameter, trigger mechanism, vacuum generation, and two-piece vs. one-piece design).
Providing Safety and Performance Data for the Modifications: This includes:
- Biocompatibility testing: Performed in accordance with ISO 10993-1, 10993-5, 10993-10, and ISO 14971:2019. Tests confirmed non-cytotoxic, non-sensitizing, and non-irritating results.
- Sterilization validation: Performed via e-beam in accordance with ANSI/AAMI/ISO 11137-2:2013.
- Performance and Safety testing: Conducted according to protocols used for the predicate device, with all results meeting acceptance criteria. The document states that newly identified risks (related to assembly) do not raise new questions of safety or effectiveness because they are identifiable before patient use.
Conclusion: The testing results support the determination of substantial equivalence, meaning the modified device is considered as safe and effective as the predicate device.

In essence, this is a clearance for a physical medical instrument based on engineering and biological testing, not an AI/ML software device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 25, 2023

Aspivix SA Mauro Rinaldi Regulatory Affairs and Quality Manager Chemin du Closel, 5 Renens, Vaud 1020 Switzerland

Re: K223866

Trade/Device Name: Carevix™ Suction Cervical Stabilizer Regulation Number: 21 CFR$ 884.4530 Regulation Name: Obstetric-Gynecologic Specialized Manual Instrument Regulatory Class: II Product Code: HDC Dated: December 23, 2022 Received: December 27, 2022

Dear Mauro Rinaldi:

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. 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.

{1}------------------------------------------------

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 and Part 809); 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,

Reginald K. Avery -S

for

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K223866

Device Name Carevix™ Suction Cervical Stabilizer

Indications for Use (Describe)

The Carevix™ Suction Cervical Stabilizer 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) SUMMARY

Submitter:	ASPIVIX SAChemin du Closel 51020 RenensSwitzerland
Contact Person:	Mauro Rinaldi,Regulatory Affairs & Quality ManagerTelephone: +41 (0) 76 379 87 97E-mail: mauro.rinaldi@aspivix.com
Date Prepared:	January 23, 2023
Name of Device:	Carevix™ Suction Cervical Stabilizer
Common Name:	Cervical Tenaculum
Product Code:	HDC (Tenaculum, Uterine)
Classification:	Class II
Regulation Name &Number:	21 CFR 884.4530 - Obstetric-gynecologic specialized manualinstrument
Predicate Device:	ASPIVIX v1.1 Cervical Suction Tenaculum (K203820)The predicate device has not been subject to a design-related recall.
Description of Device:	Carevix™ Suction Cervical Stabilizer is a sterile, single-use, two-piece device consisting of three main parts: a reloadable vacuum reserve embedded inside the main body, including a piston to generate the vacuum, an activation/deactivation push-button, and an anatomic-shaped suction head to put in contact with the cervix. The suction head includes a rod that connects the main body.The purpose of this submission is to gain clearance for a modified version of the ASPIVIX device. The function and overall use of the CarevixTM Suction Cervical Stabilizer remains the same.
Indication for Use:	The Carevix™ Suction Cervical Stabilizer is indicated to snare, grasp, hold and manipulate cervical tissue.

{4}------------------------------------------------

Comparison ofIndications for Useand TechnologicalCharacteristics withthe Subject andPredicate Device:	Carevix™ Suction CervicalStabilizer(Subject device)	ASPIVIX v1.1(Predicate device)
510(k) number	K223866	K203820
Product Code	HDC	HDC
Indication for Use	The Carevix™ Suction CervicalStabilizer is indicated to snare,grasp, hold and manipulatecervical tissue.	The ASPIVIX v1.1 Cervical SuctionTenaculum is indicated to snare,grasp, hold and manipulate cervicaltissue.
Design	Suction pad (suction head)grasps cervical tissue throughvacuum.Handle with one hand.Push button lock.	Suction pad grasps cervical tissuethrough vacuum.Handle with one hand.Sliding lock.
Material	Polycarbonate/Polyester,thermoplastic elastomer, Methylmethacrylate-Acrylonitrile-Styrene-Butadiene (MABS),	Polycarbonate/Polyester,thermoplastic elastomer, Mixture ofmethacrylic acid esters andphotoinitiator, Polypropylene likematerial and Triethyl O-acetylcitrate
Sterilization	Yes, e-beam	Yes, e-beam
Single use	Yes	Yes
Differences	The subject Carevix™ Suction Cervical Stabilizer device has the sameintended use and principle of operation as the predicate ASPIVIX v1.1device. However, the device design and materials are different. Thedesign changes include:• An increase in Rod length• An increase in inner diameter of the Rod• A new trigger mechanism• A modified vacuum generation mechanism• The subject device is designed with two-pieces compared to one-piece as in the predicate device.The difference in technological characteristics do not raise differentquestions of safety and effectiveness.
Length of Rod	208.85mm	174mm
Inner Diameter ofthe Rod	2.5mm	1.5mm
Trigger	Push button used to activate anddeactivate the vacuum	Frontward-backward slider ring usedto deactivate the vacuum
Vacuum	The piston is pulled out from themain body until it reaches theendpoint, generating vacuum.	The rod is pulled out from the bodyuntil it stops, generating vacuum.
TechnicalCharacteristic	Two-piece sterile and fullydisposable device composed offour parts and three subparts	One-piece sterile and fully disposabledevice composed of three subparts.
Indications for UseComparison	The subject and predicate device have the same intended use to snare,grasp, hold, and manipulate cervical tissue.
Safety andPerformance Data:	To support the proposed modifications to the subject device, designcontrol activities and a risk analysis (depicting device change, riskassociated, verification method, acceptance criteria, and summary ofresults) was performed. The CarevixTM Suction Cervical Stabilizer wasevaluated according to following verification and validation activities.Biocompatibility testingThe biocompatibility evaluation for Carevix™ Suction CervicalStabilizer was conducted following testing protocols used for thepredicate device ASPIVIX v1.1 in accordance with the FDA guidance"Use of International Standard ISO 10993-1, "Biological evaluation ofmedical devices - Part 1: Evaluation and testing within a riskmanagement process" in accordance with ISO 14971:2019 - Medicaldevices - application of risk management to medical devices. Testingincluded:• 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-cytotoxicnon-sensitizing, and non-irritating.
	Sterilization
	The device is provided sterile via irradiation by e-beam. Sterilizationvalidation was performed in accordance with methods equivalent toANSI/AAMI/ISO 11137-2:2013 and was conducted following testingprotocols used for the predicate device ASPIVIX v1.1.
	Performance and Safety testing
	The tests were performed to assess the performance of Carevix™ SuctionCervical Stabilizer according to the requirements specified in its designand user specifications. All tests were conducted according to theprotocols used to validate the predicate device ASPIVIX v1.1. All theresults were in accordance with the test acceptance criteria. Safety testswere not conducted as when comparing the Carevix™ device with thepredicate device ASPIVIX v1.1, the newly identified risk pertaining tothe assembly of the device does not raise a new question of safety noreffectiveness as this is done before application on the patient and miss-assembly would easily be identified when generating the vacuum prior touse on the patient.Existing risks related to the new sterilization site, changes in the materialhave been evaluated and no new question of safety or effectiveness israised based on the tests performed.
Conclusion:	The results of the testing described above demonstrate that the Carevix™Suction Cervical Stabilizer is as safe and effective as the predicate deviceand supports a determination of substantial equivalence.

{5}------------------------------------------------

{6}------------------------------------------------

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.