(123 days)
Not Found
No
The device description and performance studies focus on a mechanical anchoring system and do not mention any computational or data-driven components indicative of AI/ML.
Yes
The device is described as "anchoring sutures to ligaments of the pelvic floor," which is a corrective action for a medical condition.
No
The device description and intended use clearly state that the Apyx device is for attaching sutures to ligaments of the pelvic floor, which is a therapeutic rather than a diagnostic function.
No
The device description clearly outlines physical components including an implantable nitinol anchor, suture, cartridge, applicator, and optional retriever. These are hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Apyx Function: The Apyx device is an implantable device used to physically attach sutures to ligaments within the body (in vivo). It is a surgical tool and implant, not a diagnostic test performed on a specimen.
The description clearly indicates a device used for surgical procedures within the pelvic floor, not for analyzing biological samples.
N/A
Intended Use / Indications for Use
The Apyx is intended for attaching sutures to ligaments of the pelvic floor.
Product codes (comma separated list FDA assigned to the subject device)
PBQ
Device Description
The Apyx device is indicated for anchoring sutures to ligaments of the pelvic floor. The device consists of an implantable nitinol anchor with 4 prongs configured with either non-absorbable or resorbable suture. The anchor-suture assembly is contained within a cartridge, wherein the anchor/suture assembly is deployed to the target site from the cartridge with an applicator. An optional retriever can be used to remove the anchor in the event of sub-optimal placement of an Anchor during the index procedure.
The Apyx device is a single use device which is supplied sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvic floor
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)
Cadaver model testing was conducted to demonstrate that the Apyx instructions for use and critical operation tasks can be performed. Following the system instructions, users delivered the anchor through a transvaginal approach and then retrieved the applied anchors from their implantation site. No complications or unanticipated risks were observed throughout all anchor delivery and retrieval procedures. All anchors were accurately delivered into the target ligament and no damage to any of the surrounding structures was observed. It was therefore concluded that the Apyx device meets the design requirements and is suitable for its intended use.
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.
POP Medical Solutions, NeuGuide, K160569
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
Image /page/0/Picture/0 description: The image shows the logo for 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 text logo on the right. The FDA text logo is in blue and includes the words "FDA U.S. FOOD & DRUG ADMINISTRATION".
April 5, 2022
Escala Medical % Jonathan Kahan Partner Hogan Lovells 555 Thirteenth Street, NW Washington, DC 20004-1109
Re: K213783
Trade/Device Name: Apyx Regulation Number: 21 CFR§ 884.4530 Regulation Name: Obstetric-Gynecologic Specialized Manual Instrument Regulatory Class: II Product Code: PBQ Dated: February 28, 2022 Received: February 28, 2022
Dear Jonathan Kahan:
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); 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 (OS) 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 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) K213783
Device Name
Арух
Indications for Use (Describe)
The Apyx is intended for attaching sutures to ligaments of the pelvic floor.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ✘ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) SUMMARY
Escala Medical Apyx (K213783)
Submitter
Escala Medical Ltd.
17 Tchelet St. Misgav Business Park, 2017400 lsrael
Phone: +972.72.260.7000
Contact Person: Edit Goldberg
Date Prepared:
April 4, 2022
Name of Device:
Арух
Common or Usual Name:
Fixation device for the pelvic floor
Classification Number:
884.4530
Classification Name:
Obstetric-gynecologic specialized manual instrument
Regulatory Class:
2
Product Code:
PBQ
Product Code Name:
Fixation, Non-Absorbable or Absorbable, For Pelvic Use
Predicate Device:
POP Medical Solutions, NeuGuide, K160569
4
The predicate device has not been subject to a device design-related recall.
Device Description
The Apyx device is indicated for anchoring sutures to ligaments of the pelvic floor. The device consists of an implantable nitinol anchor with 4 prongs configured with either non-absorbable or resorbable suture. The anchor-suture assembly is contained within a cartridge, wherein the anchor/suture assembly is deployed to the target site from the cartridge with an applicator. An optional retriever can be used to remove the anchor in the event of sub-optimal placement of an Anchor during the index procedure.
The Apyx device is a single use device which is supplied sterile.
Intended Use / Indications for Use
The Apyx is intended for attaching sutures to ligaments of the pelvic floor.
Summary of Technological Characteristics
Both the subject and predicate devices are indicated for attaching sutures to ligaments of the pelvic floor. The technological characteristics of the Apyx are comparable to that of the NeuGuide predicate. Both devices comprise a nitinol anchor, which is provided with suture and delivered via an applicator. The devices are further each supplied sterile and are preloaded with the anchor-suture assembly. The minor differences between the design of the devices do not raise different questions of safety or effectiveness and the performance testing demonstrates comparable performance compared to the predicate.
| Apyx | NeuGuide (K160569) | |
|---|---|---|
| Anchor design | 4 prongs | 2 prongs |
| Anchor materials | Nitinol | Nitinol |
| Suture | Polypropylene | |
| or | ||
| Polydioxanone | Polypropylene monofilament | |
| Applicator | Yes – shaft (applicator | |
| cartridge) and handle | Yes – shaft and thimble | |
| Retriever for device removal | Yes | No |
Table 1: Summary of Technological Characteristics
5
Performance Data
- Biocompatibility testing in accordance with ISO 10993 consistent with intended duration of . contact:
- O Cytotoxicity
- Sensitization o
- Pyrogenicity o
- Irritation o
- Intracutaneous reactivity O
- Chemical characterization and toxicological risk assessment in accordance with ISO . 10993-18 to address biocompatibility endpoints of :
- Genotoxicity O
- Acute systemic toxicity o
- Chronic systemic toxicity O
- Carcinogenicity o
- Developmental/reproductive toxicity O
- Sterilization validation per ISO 11135 ●
- . Packaging validation
- Shelf-life validation .
- . Dimensional verification
- Anchor fracture resistance .
- Anchor fixation pull out .
- . Suture detachment
- Suture tensile strength ●
- . MRI compatibility
- Corrosion resistance per ASTM F2129 ●
- . Bond strength
Cadaver Testing
Cadaver model testing was conducted to demonstrate that the Apyx instructions for use and critical operation tasks can be performed. Following the system instructions, users delivered the anchor through a transvaginal approach and then retrieved the applied anchors from their implantation site. No complications or unanticipated risks were observed throughout all anchor delivery and retrieval procedures. All anchors were accurately delivered into the target
6
ligament and no damage to any of the surrounding structures was observed. It was therefore concluded that the Apyx device meets the design requirements and is suitable for its intended use.
Conclusion
The Apyx is as safe and effective as the POP Medical Solutions, NeuGuide, K160569. The Apyx has the same intended use and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the Apyx and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrates that the Apyx is as safe and effective as the NeuGuide predicate to support a substantial equivalence determination.