Foam Seal Catheter is a single channel catheter intended for use during Foam Seal Cadieter is a single endinsion sonogram. Foam Seal Catheter is a simplified version of double-channel balloon HSG catheter. This device has a single channel version of 1.6mm to 3mm in diameter and has a length of 370mm. Both ends of this catheter are open. The outer end has a luerlock device. A two way lock is attached to this end. The inner end is used to introduce fluid into the cavity of uterus. An introducer this cho. The finiter ens of agent is placed on its mid-segment. Both catherer and of an external caminate of plastic material. A cone-shaped foam component is attached close Calliula are made of placed in the cervical canal during the procedure. The foum to himel end so it can be placed find seal and to keep the catheter in place.

Fluid media is injected into the cavity of uterus using this catheter with a syringe. Thich media is injected into ax carry of on the injected fluid. Radiology procedures of ultrasound examination is performed at this time and images of the cavity of the uterus is taken. There are several advantages to this device. This is a single chamel device and is taken. There are several advantages to the cervical canal and keeps the catheter in place without the need of an assistant.

AI/ML Overview

The provided text is a 510(k) summary for the Foam Seal Catheter, which is a medical device. This document focuses on establishing substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and device performance metrics. Therefore, it does not contain the information needed to fill out most of the requested table and sections.

However, I can extract the following relevant details:

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

The document does not explicitly define acceptance criteria or report specific performance metrics for the Foam Seal Catheter. Instead, it claims substantial equivalence to a predicate device (H/S Elliptosphere Catheter set with 510K number K013972) based on "same technological characteristics," "identical intended use and operating principles." Therefore, the implicit acceptance criterion is that the device is substantially equivalent to the predicate. No quantitative performance data is provided for the Foam Seal Catheter itself.

Acceptance Criteria	Reported Device Performance
Substantial Equivalence to Predicate Device (H/S Elliptosphere Catheter set K013972)	"Same technological characteristics," "identical intended use and operating principles."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The 510(k) summary does not describe a clinical study with a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document, as no test set or ground truth establishment process is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document, as no test set or adjudication process is described.

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

This information is not provided in the document. The device is a catheter, not an AI-assisted diagnostic tool, so an MRMC study related to AI performance would not be relevant.

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

This information is not provided in the document. This is a medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided in the document, as no ground truth is described.

8. The sample size for the training set

This information is not provided in the document, as no training set is described for this type of device.

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

This information is not provided in the document, for the same reason as above.

Summary

{0}------------------------------------------------

K0835-94/

JUL 2 1 2009

510K Summary (K083594)

Submitted by:

Al Muzzammel, M.D. OBG Products 8292-C Old Courthouse Rd Vienna, VA 22182 Tel: (703) 448-8787 July 17, 2009

Device: Trade Name: Proposed Classification Name: Common/Usual Name: Regulation Number: Product Code: Class:

Foam Seal Catheter Cannula, Manipulator/Injector, Uterine HSG Catheter Unclassified LKL Unclassified

Device Description:

{1}------------------------------------------------

Predicate Device:

This Foam Seal catherer is comparable to existing predicate devices: H/S Elliptosphere Catheter set with 510K number K 013972.

Intended Use:

The Fourn Seal SIS/HSG Catheter is intended for introduction of liquid into the uterine cavity for ultrasonogram and radiology procedure of the uterus and fallopian tubes.

Summary of Technologies:

The Foam Seal Catheter has the same technological characteristics as the predicate The Four Sear Catherer has the bases. The intended use and operating principles are identical. The Foam Seat cather is individually packaged in ETO sterilized blister pack for single use.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Al Muzzammel, M.D. President OBG Products 8292-C Old Courthouse Road VIENNA VA 22182 -

JUL 2 1 2009

Re: K083594

Trade/Device Name: Foam-Seal Catheter Regulation Number: None Regulatory Class: Unclassified Product Code: LKF Dated: June 22, 2009 Received: June 24, 2009

Dear Dr. Muzzammel:

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.

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

{3}------------------------------------------------

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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Irvine M. Morris

Janine M. Morris Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

FDA U.S. Food and Drug Administration

CENTER FOR DEVICES AND RADIOLAGICAL HEALTH

Indications for use

10(K) Number (if known): 510K# K083594

Device Name: Foam-Seal Catheter

Indications for Use;

Injection of fluid into the uterine cavity during Saline Infusion sonogram (SIS) & hysterosalpinogram (HSG). Following are some Clinical Indications:

1. Infertility.
1. Menorrahagia.
1. Dysmenorrhea.
1. Suspected Endometrial Polyp.
1. Uterine Fibroid.
1. Amenorrhea due to Uterine Synechea (Asherman Syndrome).
1. Congenital Uterine Anomaly.

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)

tom Whan

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number.

Exhibit #3

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.