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 use retriever may be used to remove the anchor in the event of sub-optimal placement of an Anchor during the index procedure. The Apyx also includes an optional securement element which may be used as a suture retention device to distribute suture tension over a larger tissue area and aid in wound healing.

The Apyx device is a single use device which is supplied sterile.

AI/ML Overview

The provided text does not contain detailed acceptance criteria or a study proving the device meets those criteria in the typical format of a clinical or performance study with specific metrics like sensitivity, specificity, or AUC, as these would be associated with diagnostic or AI-powered devices.

However, based on the information provided, here's a breakdown of what can be extracted regarding performance and testing:

1. A table of acceptance criteria and the reported device performance

The document mentions various tests conducted, generally implying that the device met the requirements of these tests to demonstrate safety and effectiveness. Since specific numerical acceptance criteria (e.g., "pull-out strength > X N") and the exact reported performance values are not explicitly stated, I will infer the acceptance as "Met requirements" based on the conclusion of substantial equivalence.

Acceptance Criterion (Implied)	Reported Device Performance
Biocompatibility	Met requirements (ISO 10993 compliant)
Chemical Characterization and Toxicological Risk Assessment	Met requirements (ISO 10993-18 compliant)
Corrosion Resistance	Met requirements
Packaging Validation	Met requirements
Shelf-Life Validation	Met requirements
Securement Element Pull-Out	Met requirements
Cadaver Model Testing (Delivery)	All anchors accurately delivered into target ligament; no complications or unanticipated risks observed. Successfully performed.
Cadaver Model Testing (Retrieval)	Successfully performed. Successfully removed.
Cadaver Model Testing (Securement)	All anchors secured using the securement element and properly fixed at the desired position with ease.

2. Sample size used for the test set and the data provenance

Sample size for test set: The "Cadaver Testing" section does not specify the number of cadavers or the number of anchors tested. It uses general phrasing like "users," "all anchor delivery and retrieval procedures," and "All anchors."
Data provenance: Not explicitly stated, but cadaver testing implies a controlled laboratory environment. The country of origin of the data is not mentioned. It is prospective testing carried out for regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. The cadaver testing describes the actions of "users" (implying medical professionals) who delivered and retrieved anchors, but doesn't mention independent expert assessment or ground truth establishment in a formalized way for outcomes like accuracy or safety observed during the testing. The "ground truth" here is the observed outcome of the procedure itself (e.g., successful placement, no damage).

4. Adjudication method for the test set

Not applicable/Not described. The cadaver testing describes qualitative observations of successful delivery, retrieval, and proper fixation. There's no mention of an adjudication process for resolving disagreements between multiple observers, as might be seen in diagnostic studies.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This device is a surgical instrument (fixation device), not an imaging or AI-assisted diagnostic tool. Therefore, an MRMC study and AI-related effectiveness are not relevant or discussed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This device is a manual instrument for surgical use, not an algorithm.

7. The type of ground truth used

For the cadaver testing, the ground truth was the direct observation of the physical outcome and success of the procedure (e.g., "anchors were accurately delivered," "no damage observed," "properly fixed"). This is akin to direct experimental observation and physical verification rather than consensus, pathology, or outcomes data in a clinical trial.

8. The sample size for the training set

Not applicable. This device is a physical medical instrument, not a machine learning algorithm, so there is no "training set."

9. How the ground truth for the training set was established

Not applicable, as there is no training set for a physical medical instrument.

Summary

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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.

July 25, 2023

Escala Medical % Lina R. Kontos Partner Hogan Lovells 555 Thirteenth Street. NW Washington, DC 20004-1109

Re: K230730

Trade/Device Name: Apyx Regulation Number: 21 CFR§ 884.4530 Regulation Name: Obstetric-Gynecologic Specialized Manual Instrument Regulatory Class: II Product Code: PBQ Dated: June 26, 2023 Received: June 27, 2023

Dear Lina R. Kontos:

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.

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Page 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/cdrl-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

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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K230730

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)

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

Escala Apyx

Submitter

Escala Medical LTD. 17 Tchelet St. Misgav Business Park 2017400 Israel

Phone: +972.72.260.7000

Contact Person: Edit Goldberg, CEO

Date Prepared: July 13, 2023

Name of Device: Apyx

Common or Usual Name: Fixation device for the pelvic floor

Classification Number: 884.4530

Classification Name: Obstetric-gynecologic specialized manual instrument

Requlatory Class: II

Product Code: PBQ

Product Code Name: Fixation, Non-Absorbable or Absorbable, For Pelvic Use

Predicate Device: Escala Medical Ltd., Apyx, K213783

The predicate device has not been subject to a design-related recall.

Device Description

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.

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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 identical to that of the previously cleared Apyx device, i.e., the predicate devices include a nitinol anchor, which is provided with the attached suture and delivered using an applicator. The devices are supplied sterile by ethylene oxide and are pre-loaded with the anchor-suture assembly. The difference between the subject device and the predicate device is the inclusion of the securement. The inclusion of this optional component is evaluated with similar testing as the predicate device and accordingly does not raise different questions of safety or effectiveness.

	Subject DeviceApyx (K230730)	Predicate DeviceApyx (K213783)
Anchor design	4 prongs	4 prongs
Anchor materials	Nitinol and optional stainlesssteel securement element	Nitinol
Suture	Polypropylene orPolydioxanone	Polypropylene orPolydioxanone
Applicator	Yes - shaft (applicatorcartridge) and handle	Yes – shaft (applicatorcartridge) and handle
Securement element	Yes (optional - per physiciandiscretion)	No
Retriever for device removal	Yes (optional – per physiciandiscretion)	Yes (optional - per physiciandiscretion)

Performance Data

Testing to support the modified device with the optional securement included:

. Biocompatibility testing in accordance with the 2020 FDA quidance document Use of International Standard ISO 10993-1. "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" and ISO 10993 consistent with intended duration of contact:
- Cytotoxicity o
- O Sensitization
- Pyrogenicity O
- Irritation O
- Intracutaneous reactivity O
. Chemical Characterization and toxicological risk assessment in accordance with ISO 10993-18 to address biocompatibility endpoints of:
- O Genotoxicity
- O Acute systemic toxicity
- Chronic systemic toxicity O
- Carcinogenicity O
- Developmental/reproductive toxicity O
Corrosion resistance ●
Packaging validation
Shelf-life validation ●
Securement element pull out

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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 ligament and no damage to any of the surrounding structures was observed. All anchors were secured using the securement element and were noted to be properly fixed at the desired position with ease. It was therefore concluded that the Apyx device meets the design requirements and is suitable for its intended use.

Conclusions

The Apyx has the same intended use and identical indications, and substantially similar technological characteristics, and principles of operation as its predicate device. The sole difference between the Apyx and its predicate device (optional securement element) does not raise any different questions of safety or effectiveness. Performance data demonstrates that the Apyx with the optional securement element is as safe and effective as the predicate device to support a substantial equivalence determination.

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.