The FemChec™ Pressure Management Device limits the maximum applied pressure while instilling contrast media into the uterus and fallopian tubes. It is to be used in conjunction with an intrauterine catheter for performance of hysterosalpingogram (HSG), such as tubal occlusion confirmation tests in women who have had tubal procedures for permanent female sterilization. The FemChec limits the applied intrauterine pressure to 200 mmHg.

The FemChec is provided with a fluid collector, stopcock, and intrauterine catheter for performing the HSG procedure.

Device Description

The FemChec Pressure Management Device (FemChec) is a pressure-limiting contrast media syringe that is connected to an intrauterine catheter for low-pressure instillation of contrast media during HSG procedures.

AI/ML Overview

Here's an analysis of the FemChec™ Pressure Management Device's acceptance criteria and the study used to demonstrate its performance, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance for FemChec™ Pressure Management Device

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Functional/Performance Aspects)	Reported Device Performance (as demonstrated by testing)
Fluid instilling function of syringe	Confirmed (implied by "fluid instilling function of syringe" test)
Attachment functionality	Confirmed (implied by "attachment functionality" test)
Single-hand actuation	Confirmed (implied by "single-hand actuation" test)
Pressure testing < 200 mm Hg	Limits applied intrauterine pressure to 200 mmHg
Biocompatibility (cytotoxicity, irritation, sensitization, acute systemic toxicity)	Confirmed (according to ISO 10993 standards)

2. Sample Size and Data Provenance

The provided document describes non-clinical methods used for testing. This means the testing was likely conducted in a laboratory setting or on simulated systems, not on human subjects.

Sample Size for Test Set: The document does not specify the exact number of devices or components tested for each criterion. It only lists the types of tests performed.
Data Provenance: The data is from non-clinical testing, meaning it's not derived from human patients. The country of origin for the data is not explicitly stated, but given the 510(k) submission to the FDA, it would typically be generated by the manufacturer's own internal testing or by a contracted lab, likely in the US or a country with comparable regulatory standards. The testing is prospective in the sense that it was conducted specifically to support this regulatory submission.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: Not applicable. Since the testing was non-clinical, there were no human experts establishing a "ground truth" for the performance characteristics in the way they would for a diagnostic accuracy study. The "ground truth" for the functional tests (e.g., pressure limiting) would have been defined by the device's design specifications and accepted engineering principles, verified through instrument measurements.
Qualifications of Experts: Not applicable for establishing ground truth in this context. The "experts" involved would be engineers and lab technicians conducting the tests according to established protocols.

4. Adjudication Method

Adjudication Method: Not applicable. Non-clinical performance testing typically involves objective measurements against predefined specifications, rather than subjective interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was an MRMC study done? No. The submission describes non-clinical performance testing, not a clinical study involving human readers.
Effect size of human readers improve with AI vs without AI assistance: Not applicable, as no MRMC study was conducted, and the device is a mechanical pressure management system, not an AI-powered diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

Was a standalone study done? Yes, in a sense. The described testing focuses solely on the performance of the device itself (e.g., its ability to limit pressure, its biocompatibility, its functionality) in a laboratory setting, independent of human interaction beyond operating the device. However, "standalone" in this context typically refers to AI algorithm performance without human intervention, which is not relevant here.

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth for the non-clinical tests was based on engineering specifications and objective measurements. For instance, the "pressure testing < 200 mm Hg" would involve measuring the pressure exerted by the device and verifying it does not exceed the 200 mmHg limit. Biocompatibility relies on adherence to established international standards (ISO 10993).

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device is a mechanical medical device, not a machine learning or AI-based system. Therefore, there is no "training set" in the context of algorithm development.

9. How Ground Truth for the Training Set Was Established

How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this type of device.

Summary

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K110993.

OCT 1 2 2011

510(k) Summary for the FemChec™ Pressure Management Device

Date of Summary: May 31, 2011

510(k) Submitter and Primary Contact:

Lisa Peacock Vice President, Regulatory Affairs Femasys Inc. 5000 Research Court Suite 100 Suwanee, GA 30024 Tel: 770-500-3910 Fax: 770-500-3980 LPEACOCK@FEMASYS.COM

Device Common

contrast media syringe

LKF

unassigned

unclassified

Obstetrics/Gynecology

Name:

FDA Device

cannula, manipulator/injector, uterine Classification Name:

Product Code:

Classification Regulation:

Device Class:

Panel:

Indication for Use:

Device Description:

The FemChec is provided with a fluid collector, stopcock, and intrauterine catheter for performing the HSG procedure.

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KII0993

510(k) Summary for the FemChec™ Pressure Management Device

Predicate Devices:

K020954 H/S Elliptosphere Procedure Tray K792134 Bonchek Vein Distention System. 200 mm Ha K082725 VasoShield Pressure Controlling Syringe

The FemChec is similar to the H/S Elliptosphere Procedure Tray in that FemChec is a manually operated piston syringe for contrast media instillation, as an accessory to an intrauterine catheter for HSG procedures. Likewise, the predicate tray contains accessories to intrauterine catheters for HSG procedures, including a manually operated piston syringe for contrast media instillation.

The FemChec is similar to the Bonchek Vein Distention System, 200 mm Hq, in that both devices: 1) are svringes for instilling fluids, 2) contain pressure management components, and 3) limit applied pressures to a similar value. The devices differ in the mechanisms of operation and materials of the pressure management component and in their labeled anatomical locations of use, as Bonchek is labeled for use in cardiovascular applications. Although, the clinical use of the Bonchek to limit applied intrauterine pressure during HSG tubal occlusion confirmation tests was reported in the PMA Summary of Safety and Effectiveness Data for the Adiana Permanent Contraception System.

The FemChec is similar to the VasoShield Pressure Controlling Syringe in that both devices: 1) are syringes for instilling fluids, 2) contain pressure management components with similar mechanisms of operation and with similar materials, and 3) limit applied pressures to a similar value. The devices differ in the anatomical locations of use, as VasoShield is indicated for use in cardiovascular applications. ·

Summary of Testing:

The FemChec was tested by the following non-clinical methods to demonstrate that the device is substantially equivalent to the predicate devices in functionality, safety, and effectiveness:

· fluid instilling function of syringe
· attachment functionality
· single-hand actuation
· pressure testing < 200 mm Hg
· biocompatibility of components according to ISO 10993 standards: cytotoxicity, irritation, sensitization, and acute systemic toxicity

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510(k) Summary for the FemChec™ Pressure Management Device

Conclusions of Substantial Equivalence Demonstrations

The FemChec was compared to the predicate H/S Elliptosphere Procedure Tray for the following aspects, and found to have similar technological characteristics and to be substantially equivalent:

· Indications for use, regarding instillation of contrast media during HSG procedures
· Syringe design
· Syringe materials
Instillation principles of operation
· Sterility

The FemChec was compared to the predicates Bonchek Vein Distention System, 200 mm Hg and the VasoShield Pressure Controlling Syringe for the following aspects, and found to have similar technological characteristics and to be substantially equivalent:

· Indications for use, regarding limiting pressure
· Pressure management components and materials (compared to VasoShield) ·
· Pressure management principles of operation
· Sterility

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter.

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

Ms. Lisa Peacock V.P. Regulatory Affairs Femasys Inc. 5000 Research Court, Ste. 100 SUWANEE GA 30024

0CT 1 2 2011

Re: K110993

Trade/Device Name: FemChec™ Pressure Management Device Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: LKF Dated: September 23, 2011 Received: October 6, 2011

Dear Ms. Peacock:

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 of medical device-related

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Page 2

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 clectronic 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,

Huker Lemur MD

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health.

Enclosure

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Femasys Inc.

Page 1 of 1

Indications for Use

510(k) Number (if known): K110993

Device Name: FemChec™ Pressure Management Device

Indications for Use:

The FemChec is provided with a fluid collector, stopcock, and intrauterine catheter for performing the HSG procedure.

Prescription Use × (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)

_on Sign Off

( vision Sign-Off Lision of Reproductive. Gast Unclogical Devices 515(k) Number

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.