(33 days)
Not Found
No
The device description and performance studies focus on mechanical function, biocompatibility, and sterilization, with no mention of AI/ML, image processing, or data training/testing.
No.
The device's intended use is to "snare, grasp, hold and manipulate cervical tissue," which describes a manipulative or diagnostic function, not a direct therapeutic treatment of a disease or condition. While it aids in procedures that might be therapeutic, the device itself is not therapeutic.
No
Explanation: The device is a cervical stabilizer used to "snare, grasp, hold and manipulate cervical tissue," which are actions related to physical manipulation for stabilization or access rather than diagnosing a condition. Its function is to facilitate procedures, not to identify or characterize medical conditions.
No
The device description clearly outlines physical components like a vacuum reserve, piston, push-button, and suction head, indicating it is a hardware device.
Based on the provided information, this device 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 in vivo (within the body), not a test performed in vitro (outside the body) on biological samples to diagnose a condition.
- Device Description: The description details a mechanical device with a suction head designed to interact directly with the cervix. This aligns with a surgical or procedural tool, not a diagnostic test kit or instrument.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, or tissue samples), detecting biomarkers, or providing diagnostic information based on laboratory testing.
Therefore, the Carevix™ Suction Cervical Stabilizer is a medical device used for physical manipulation of tissue, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Carevix™ Suction Cervical Stabilizer is indicated to snare, grasp, hold and manipulate cervical tissue.
Product codes
HDC
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
To support the proposed modifications to the subject device, design control activities and a risk analysis (depicting device change, risk associated, verification method, acceptance criteria, and summary of results) was performed. The CarevixTM Suction Cervical Stabilizer was evaluated according to following verification and validation activities.
Biocompatibility testing: The biocompatibility evaluation for Carevix™ Suction Cervical Stabilizer was conducted following testing protocols used for the predicate device ASPIVIX v1.1 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" in accordance with ISO 14971:2019 - Medical devices - application of risk management to medical devices. 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 and was conducted following testing protocols used for the predicate device ASPIVIX v1.1.
Performance and Safety testing: The tests were performed to assess the performance of Carevix™ Suction Cervical Stabilizer according to the requirements specified in its design and user specifications. 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. Safety tests were not conducted as when comparing the Carevix™ device with the predicate device ASPIVIX v1.1, the newly identified risk pertaining to the assembly of the device does not raise a new question of safety nor effectiveness as this is done before application on the patient and miss-assembly would easily be identified when generating the vacuum prior to use on the patient.
Existing risks related to the new sterilization site, changes in the material have been evaluated and no new question of safety or effectiveness is raised based on the tests performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
ASPIVIX v1.1 Cervical Suction Tenaculum (K203820)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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.
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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
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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)
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510(k) SUMMARY
| Submitter: | ASPIVIX SA
Chemin du Closel 5
1020 Renens
Switzerland |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mauro Rinaldi,
Regulatory Affairs & Quality Manager
Telephone: +41 (0) 76 379 87 97
E-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 manual
instrument |
| 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. |
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| Comparison of
Indications for Use
and Technological
Characteristics with
the Subject and
Predicate Device: | Carevix™ Suction Cervical
Stabilizer
(Subject device) | ASPIVIX v1.1
(Predicate device) |
|---------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | K223866 | K203820 |
| Product Code | HDC | HDC |
| Indication for Use | The Carevix™ Suction Cervical
Stabilizer is indicated to snare,
grasp, hold and manipulate
cervical tissue. | The ASPIVIX v1.1 Cervical Suction
Tenaculum is indicated to snare,
grasp, hold and manipulate cervical
tissue. |
| Design | Suction pad (suction head)
grasps cervical tissue through
vacuum.
Handle with one hand.
Push button lock. | Suction pad grasps cervical tissue
through vacuum.
Handle with one hand.
Sliding lock. |
| Material | Polycarbonate/Polyester,
thermoplastic elastomer, Methyl
methacrylate-Acrylonitrile-
Styrene-Butadiene (MABS), | Polycarbonate/Polyester,
thermoplastic elastomer, Mixture of
methacrylic acid esters and
photoinitiator, Polypropylene like
material 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 same
intended use and principle of operation as the predicate ASPIVIX v1.1
device. However, the device design and materials are different. The
design 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 different
questions of safety and effectiveness. | |
| Length of Rod | 208.85mm | 174mm |
| Inner Diameter of
the Rod | 2.5mm | 1.5mm |
| Trigger | Push button used to activate and
deactivate the vacuum | Frontward-backward slider ring used
to deactivate the vacuum |
| Vacuum | The piston is pulled out from the
main body until it reaches the
endpoint, generating vacuum. | The rod is pulled out from the body
until it stops, generating vacuum. |
| Technical
Characteristic | Two-piece sterile and fully
disposable device composed of
four parts and three subparts | One-piece sterile and fully disposable
device composed of three subparts. |
| Indications for Use
Comparison | The subject and predicate device have the same intended use to snare,
grasp, hold, and manipulate cervical tissue. | |
| Safety and
Performance Data: | To support the proposed modifications to the subject device, design
control activities and a risk analysis (depicting device change, risk
associated, verification method, acceptance criteria, and summary of
results) was performed. The CarevixTM Suction Cervical Stabilizer was
evaluated according to following verification and validation activities.
Biocompatibility testing
The biocompatibility evaluation for Carevix™ Suction Cervical
Stabilizer was conducted following testing protocols used for the
predicate device ASPIVIX v1.1 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" in accordance with ISO 14971:2019 - Medical
devices - application of risk management to medical devices. 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 and was conducted following testing
protocols used for the predicate device ASPIVIX v1.1. | |
| | Performance and Safety testing | |
| | The tests were performed to assess the performance of Carevix™ Suction
Cervical Stabilizer according to the requirements specified in its design
and user specifications. 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. Safety tests
were not conducted as when comparing the Carevix™ device with the
predicate device ASPIVIX v1.1, the newly identified risk pertaining to
the assembly of the device does not raise a new question of safety nor
effectiveness as this is done before application on the patient and miss-
assembly would easily be identified when generating the vacuum prior to
use on the patient.
Existing risks related to the new sterilization site, changes in the material
have been evaluated and no new question of safety or effectiveness is
raised 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 device
and supports a determination of substantial equivalence. | |
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