The device is to be used by physicians in hospitals. The HSG catheter set consists of two parts: a double lumen catheter and a semi-rigid introducing sheath. The catheter is available in two different sizes 5 and 7 French diameter with a length of 30 cm. The distal end has a side port and a non-latex Kraton balloon whose capacity is 1.5 cc for 5F and 3cc for 7F. The proximal end that ends in side port is fitted with a halkey clamp and female luer lock hub. The other channel is fitted with one way stop cock and a 3cc syringe.

AI/ML Overview

The provided text is a 510(k) summary for the HSG Catheter Set (5F and 7F). This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than detailed clinical study data showing primary safety and effectiveness.

Therefore, the document does not contain a traditional study with acceptance criteria and reported device performance in the way a clinical trial for a new drug or a novel, high-risk device would. Instead, it relies on demonstrating that its technological characteristics are equivalent to a predicate device that has already been deemed safe and effective.

Here's an analysis based on the provided text, addressing your points where possible:

Acceptance Criteria and Device Performance

The acceptance criteria here are implicitly met by demonstrating "substantial equivalence" to the predicate device. The performance is deemed "Identical" to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance (Comparison to Predicate)
Indications for Use	Identical
Target Population	Identical
Design	Identical
Materials	Identical
Performance	Identical
Sterility	Similar (Ethylene Oxide instead of Gamma)
Biocompatibility	Identical
Mechanical safety	Identical
Chemical safety	Identical
Anatomical sites	Identical
Human factors	Identical
Energy used and/or delivered	Identical
Compatibility with environment and other devices	Identical
Where used	Identical
Standards met	Identical
Electrical safety	Identical (not applicable)
Thermal safety	Identical (not applicable)
Radiation safety	Identical (not applicable)

Study Proving Acceptance Criteria:
The "study" in this context is the 510(k) submission itself, where the manufacturer provides a detailed comparison of their device to a legally marketed predicate device (K943494 from Lyco Enterprises. Inc.). The FDA reviewed this descriptive information and concluded that the device is substantially equivalent, thereby accepting the manufacturer's claim of identical performance and safety, with a minor difference in sterilization method.

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

This document does not mention a test set with a specific sample size for evaluating the new device's performance in a clinical or user-based study. The determination of substantial equivalence is primarily based on a comparison of technological characteristics with the predicate device, not on new clinical performance data from a test set.

The data provenance for the comparison itself is the manufacturer's internally generated comparison table and potentially existing data/information from the predicate device within FDA files or literature.

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

This information is not applicable or not provided in the context of this 510(k) summary. "Ground truth" for a test set, typically established by experts, is relevant for performance studies (e.g., diagnostic accuracy for AI devices). This submission focuses on demonstrating equivalence through comparison of design, materials, and intended use, not through a new performance study requiring expert ground truth.

4. Adjudication Method for the Test Set

This information is not applicable or not provided. Without a specific test set or performance study, there's no need for an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices to assess the impact of AI assistance on human reader performance. This device is a catheter for hysterisalpingography, and the submission's focus is substantial equivalence based on design and materials, not diagnostic interpretation.

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

No, a standalone performance study was not done. This concept is primarily relevant for AI algorithms. The HSG Catheter Set is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" used here is a comparison to the established characteristics of the predicate device (Lyco Enterprises. Inc.'s HSG Catheter Set, K943494). The predicate device serves as the benchmark against which the new device's technological characteristics, safety, and performance are evaluated for equivalence. This is not "expert consensus," "pathology," or "outcomes data" for the new device, but rather a reference to an already cleared device's known attributes.

8. The Sample Size for the Training Set

This information is not applicable or not provided. There is no "training set" in the context of this 510(k) submission. Training sets are relevant for machine learning algorithms.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable or not provided. As there is no training set mentioned, there is no method for establishing its ground truth.

Summary

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510(k) Summary NOV 1 9 2001 As Required by 21 section 807.92 ( c )

1-Submitter Name: A & A Medical, Inc.
2-Address: 9370 Industrial Trace
Alpharetta, GA 30004 3-Phone:
(770) 343- 8400 4-Fax: (770) 343- 8985
Jay Mansour 5-Contact Person:
6-Date summary prepared: October 17th, 2001
7-Device Trade or Proprietary Name: HSG Catheter Set (5F and 7F)
8-Device Common or usual name: Catheter for Hysterosalpingography
9-Device Classification Name: Cannula, Manipulator/Injector. Uterine
10-Substantial Equivalency is claimed against the following device:
- . HSG Catheter Set for Hysterosalpingography, from Lyco Enterprises. Inc.
11-Description of the Device:
The device is to be used by physicians in hospitals

The HSG catheter set consists of two parts: a double lumen catheter and a semi-rigid introducing sheath.

The catheter is available in two different sizes 5 and 7 French diameter with a length of 30 cm. The distal end has a side port and a non-latex Kraton balloon whose capacity is 1.5 cc for 5F and 3cc for 7F.

The proximal end that ends in side port is fitted with a halkey clamp and female luer lock hub. The other channel is fitted with one way stop cock and a 3cc syringe.

12-Intended use of the device:

The 5F and 7F HSG Catheter set is a device used to fill the uterus with sterile saline to facilitate the ultrasound examination of the uterus

13-Safety and Effectiveness of the device:

This device is safe and effective as the other predicate device cited above. This is better expressed in the tabulated comparison (Paragraph 14 below)

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14-Summary comparing technological characteristics with other predicate device:

Please find below a tabulated comparison supporting that this device is substantially equivalent to other medical devices in commercial distribution. Also, Equivalency overview chart path is attached.

FDA file reference number	510k K943494
Attachments inside notificationsubmission file	REFER TO TABLE ON PAGE 11 OF 12 FORDETAILS
TECHNOLOGICALCHARACTERISTICS	Comparison result
Indications for use	Identical
Target population	Identical
Design	Identical
Materials	Identical
Performance	Identical
Sterility	Similar (Ethylene Oxide instead of Gamma)
Biocompatibility	Identical
Mechanical safety	Identical
Chemical safety	Identical
Anatomical sites	Identical
Human factors	Identical
Energy used and/or delivered	Identical
Compatibility with environmentand other devices	Identical
Where used	Identical
Standards met	Identical
Electrical safety	Identical (not applicable)
Thermal safety	Identical (not applicable)
Radiation safety	Identical (not applicable)

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510(k) "SUBSTANTIAL EQUIVALENCE" DECISION-MAKING PROCESS (DITAILED)

Image /page/2/Figure/2 description: This image is a flowchart that outlines the process for determining if a new device is substantially equivalent to a marketed device. The flowchart starts with the question, "New Device is Compared to Marketed Device" and proceeds through a series of questions about the device's intended use, technological characteristics, and performance data. The flowchart ends with a determination of whether the new device is "Substantially Equivalent" or "Not Substantially Equivalent".

SIO(k) submissions compare new devices to marketed devices. FDA requests additional inforclarions in the relations big between marketed and "predicate" (pre-Amendments or reclassified post-Amendments) devices is unders.

· This decision is normally based on descriptive information alone, but limited testing information is sometimes required.

*** Data may be in the 310(k), other S10(k)s, the Center's classification files, or the linerature.

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around an emblem. The emblem is a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The overall design is simple and conveys a sense of official government affiliation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 9 2001

Mr. Jay Mansour, MSQA, BE, LA, RAC Quality and Regulatory Manager A & A Medical, Inc. 9370 Industrial Trace ALPHARETTA GA 30004

Re: K013491

Trade/Device Name: HSG Catheter Set (5F and7F) Model R65-947 and R65-948 Regulation Number: None Regulatory Class: Unclassified Product Code: 85 LKF Dated: October 17, 2001 Received: October 22, 2001

Dear Mr. Mansour:

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); 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.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket I ills letter will anow you to ocgin nationing your device of your device to a legally marketed noutication. The I Dri- inding of succiantial for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please IT you desire specific advice for your de of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, 101 questions on the premes . Also, please note the regulation entitled, "Misbranding Other of Comphanes at (2017 077 100 (21 CFR Part 807.97). Other general information on by relefence to promation of the Act may be obtained from the Division of Small Manufacturers, your lesponsibilities under the rice may of its toll-free number (800) 638-2041 or (301) 443-6597 niccilational and Oolisamer : Itsitive.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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NOV 1 9 2001

of Page

510(k) Number (if known): ___K013491

Device Name: HSG Catheter Set (5F & 7F)

Indications For Use:

HSG Catheter Set (5F & 7F) is indicated for use to fill the uterus with sterile saline to facilitate the ultrasound examination of the uterus.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use v (Per 21 CFR 801.109) Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 3-10-98)

Ylancy C. Cropton

(Division Sten-Off)
Division of aoducthminal.
and Rediefental Devic
510kl N
K013491

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.