The ANCHORSURE device is a suture kit used for attaching sutures to ligaments of the pelvic floor. The submission evaluates the device against its predicate, the GYNECARE PROLENE FASTENER SYSTEM (K042603).

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the ANCHORSURE device are based on demonstrating that it meets established performance requirements and standards. The reported device performance is that it "meets the established performance requirements and standards."

Performance Test	Acceptance Criteria (Implied)	Reported Device Performance
Sterilization	Ethylene oxide residuals within limits, Ethylene chlorohydrins residuals within limits, Sterility assurance level (SAL) determination met.	Meets established requirements and standards.
Packaging	Accelerated Aging Study results confirm package integrity and shelf stability.	Meets established requirements and standards.
Biocompatibility	Biocompatibility requirements met (supported by prior device testing).	Meets established requirements and standards (via K102815 support).
Mechanical Tests	Suture strength per USP 881, Anchor strength, Suture diameter per USP 861, Pullout strength of the anchor, Tensile strength of the suture-anchor interface per USP 871.	Meets established requirements and standards.

Note: The document states that "Results of verification testing indicate that the product meets the established performance requirements and standards." Specific numerical acceptance values are not provided in this summary but are implied by adherence to standards like USP.

Study Details

Based on the provided information, the studies conducted are performance tests primarily focused on the physical and material properties of the device, rather than a clinical study evaluating human outcomes or an AI-driven analysis.

2. Sample Size Used for the Test Set and Data Provenance:

Test Set Sample Size: Not explicitly stated for each test. The sample sizes would be determined by the specific protocols for each performance test (e.g., number of sutures tested for strength, number of anchors for pullout strength).
Data Provenance: The tests are likely performed in a laboratory setting by the manufacturer, Neomedic International, S.L., located in Spain, or by a contract testing facility. This is an in vitro evaluation, not involving human subjects or real-world clinical data. Therefore, the concept of "country of origin of the data" in a clinical sense, or "retrospective/prospective," is not directly applicable.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. For these performance tests, "ground truth" is established by adherence to recognized national and international standards and test methods (e.g., USP standards for materials and mechanical properties, ISO standards for sterilization and biocompatibility). The expertise lies in performing the tests according to these standards and interpreting the results against the specified criteria. There isn't a "ground truth" established by human experts in the context of clinical interpretation or diagnosis.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or image-based evaluations where multiple human readers assess a case. For physical performance tests, the results are typically quantitative measurements that are compared directly to pre-defined numerical or qualitative acceptance criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. An MRMC study is not relevant here as this is a physical device undergoing performance testing, not a diagnostic or AI-assisted system that would involve human readers interpreting cases.

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

No. This is not an AI-enabled device or an algorithm. It's a physical surgical tool.

7. The Type of Ground Truth Used:

For sterilization, packaging, and mechanical tests, the ground truth is established by adherence to industry-recognized standards and test methods (e.g., USP, ISO).
For biocompatibility, the ground truth was "biocompatibility testing completed on the Surelift Prolapse System (K102815) was used to support the biocompatibility of Anchorsure." This means the biocompatibility of the materials used in Anchorsure was confirmed by previous, cleared testing of a similar device using the same materials, ensuring compliance with relevant biocompatibility standards.

8. The Sample Size for the Training Set:

Not applicable. There is no "training set" as this is not a machine learning model or an AI algorithm.

9. How the Ground Truth for the Training Set was Established:

Not applicable. (See point 8).

In summary, the ANCHORSURE device underwent rigorous laboratory-based performance testing against established industry standards for sterilization, packaging, biocompatibility, and mechanical properties. The aim was to demonstrate that the device's physical and material characteristics meet the necessary safety and effectiveness requirements, rather than evaluating its performance in a clinical setting with human readers or AI algorithms.

Summary

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D 117

DIMA	510K SUMMARY	K120831
SUBMITTER:	Neomedic International, S.L.C/ Maestrat 41-43 1º08225 Terrassa (Barcelona)Spain	Page
CONTACT PERSON:	Jeffrey Shideman, Ph.D.
DATE PREPARED:	October 10th 2012
DEVICE NAME:	ANCHORSURE
REGULATION NUMBER:	21 CFR 884.4530
REGULATION NAME:	Obstetric-gynecologic specialized manual instrument
PRODUCT CODE:	PBQ
PREDICATE DEVICES:	GYNECARE PROLENE FASTENER SYSTEM (K042603)

Device Description:

Anchorsure is a suture kit that consists of monofilament polypropylene suture, an anchor, an anchoring handle, and a surgical needle.

Description of material components and physical properties:

Component	Material
Suture	Polypropylene monofilament
Anchor	PEEK
Anchoring Handle	Stainless steel AISI 303POM
Surgical Needle	Stainless steel

Component	Properties
Monofilament polypropylene suture	USP 0Diameter: 0.4 mmLength: 800 mm
Anchor	Diameter: 3 mmLength: 7 mm
Anchoring Handle	Anchoring Handle tube diameter = 6 mmAnchoring Handle tube length = 204 mm
Surgical Needle	Diameter: 1.1 mmCurved diameter: 20 mm

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510K SUMMARY

Predicate Devices:

The following device has been previously cleared by the FDA in the following 510(K):

Device	510 (K)documentnumber	Date Cleared	Indications
GYNECARE PROLENE FASTENERSYSTEM	K042603	December 22nd2004	Suture kit

Intended Use:

Anchorsure is indicated for attaching suture to ligaments of the pelvic floor.

Technological Characteristics:

Anchorsure and the Gynecare Prolene Fastener do not have the same technological characteristics because Anchorsure is a suture kit and the Gynecare Prolene Fastener is a staple. The new technological characteristics of the Anchorsure could affect safety and effectiveness. However, the new characteristics do not raise new issues of safety and effectiveness because both devices are used to attachments to the pelvic floor. Accepted scientific methods exist to assess the effects of the new characteristics - specifically those described in the "Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA" issued on June 3, 2003.

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DIMA

Performance tests:

Performance test	Test description
Sterilization	Ethylene oxide residualsEthylene chlorohydrins residualsSterility assurance level (SAL) determination
Packaging	Accelerated Aging Study
Biocompatibility	Biocompatibility testing completed on the Surelift ProlapseSystem (K102815) was used to support thebiocompatibility of Anchorsure.
Mechanical tests	Suture strength evaluated per USP 881.Anchor strengthSuture diameter evaluated per USP 861.Pullout strength of the anchorTensile strength of the suture-anchor interface evaluatedper USP 871

Results of verification testing indicate that the product meets the established performance requirements and standards.

Conclusions:

Anchorsure is substantially equivalent to its proposed predicate device.

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Image /page/3/Picture/0 description: The image is a seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is an image of an eagle with its wings spread.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Neomedic International S.L. % Jeffrey R. Shideman, Ph.D. President International Medical Products Corporation 7307 Glouchester Drive EDINA MN 55435

Re: K120831

Trade/Device Name: ANCHORSURE Regulation Number: 21 CFR§ 884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulatory Class: II Product Code: PBQ Dated: September 6, 2012 Received: September 10, 2012

Dear Dr. Shideman:

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. 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. 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 (reporting of medical

OCT 12 2012

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Benjamin K. Eubanks

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K120831

Device Name: ANCHORSURE

Indications for Use:

Anchorsure is indicated for attaching suture to ligaments of the pelvic floor

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page __ of

Norma M. Whaley

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K120831

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.