THE SONOHYSTEROGRAPHY CATHETER (5 Fr) IS INDICATED FOR USE TO FILL THE UTERUS WITH STERILE SALINE TO FACILITATE THE ULTRASOUND EXAMINATION OF THE UTERUS

Device Description

The 5F SH catheter consists of two parts: a single lumen catheter and a semi-rigid introducing sheath. The catheter is available in a 5 French diameter with a length of 32 cm. The distal end has a side port. The proximal end is fitted with a female luer-lock hub. The catheter is banded with a non-toxic ink 7 cm from the distal tip. The semi-rigid sheath has an internal diameter to allow movement over the catheter and a wall thickness sufficient to provide semi-rigid flexibility. The sheath is 17.5 cm long and flanged and rounded at the distal end to provide a non-traumatic surface to the tissues. The proximal end allows for temporary fixation over the proximal hub of the catheter.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device (5F SH Catheter) claiming substantial equivalence to a predicate device. This type of submission does not typically include detailed studies with acceptance criteria for device performance as a standalone product in the way AI/ML algorithms or novel devices would. Instead, the focus is on demonstrating that the new device is as safe and effective as a legally marketed predicate device, largely based on a comparison of technological characteristics.

Therefore, many of the requested points regarding acceptance criteria, study details, sample sizes, expert ground truth, and comparative effectiveness studies are not applicable or not explicitly detailed in this type of regulatory document.

However, I can extract the relevant information where available and explain why other points are not present based on the nature of a 510(k) submission for this specific device.

Description of Acceptance Criteria and Study for the 5F SH Catheter

The acceptance criteria and "study" for this device are fundamentally wrapped in the concept of Substantial Equivalence (SE) to a predicate device. The performance of the new device is accepted if it is demonstrated to be identical or similar enough to a legally marketed predicate device such that it raises no new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Criterion (Technological Characteristic)	Acceptance Criteria (Compared to Predicate)	Reported Device Performance (vs. Predicate)
Indications for use	Identical	Identical
Target population	Identical	Identical
Design	Identical	Identical
Materials	Identical	Identical
Performance	Identical	Identical
Sterility	Similar (no new safety/effectiveness questions)	Similar (Ethylene Oxide instead of Gamma)
Biocompatibility	Identical	Identical
Mechanical safety	Identical	Identical
Chemical safety	Identical	Identical
Anatomical sites	Identical	Identical
Human factors	Identical	Identical
Energy used and/or delivered	Identical	Identical
Compatibility with environment and other devices	Identical	Identical
Where used	Identical	Identical
Standards met	Identical	Identical
Electrical safety	Identical (not applicable)	Identical (not applicable)
Thermal safety	Identical (not applicable)	Identical (not applicable)
Radiation safety	Identical (not applicable)	Identical (not applicable)

Explanation: The "study" in this context is the comparison itself, as presented in the "Summary comparing technological characteristics with other predicate device" (Section 14). The acceptance criterion for each characteristic is that the new device must be "Identical" to the predicate, or "Similar" in a way that doesn't raise new safety or effectiveness concerns (e.g., sterilization method). The reported "performance" for the new device is its characteristic relative to the predicate, as shown in the "Comparison result" column.

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

Not Applicable / Not Provided: For a device like a catheter seeking substantial equivalence through a direct comparison of characteristics, a "test set" in the sense of clinical data or image data is typically not required or detailed in this summary. The comparison is based on the design, materials, and intended use of the device itself against the predicate. If any limited testing was performed (e.g., for biocompatibility or mechanical safety), the sample size and provenance are not disclosed in this 510(k) summary. The document states "limited testing information is sometimes required," but does not provide details for this specific submission.

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)

Not Applicable / Not Provided: Since there isn't an explicit "test set" or diagnostic performance claim being evaluated via expert review, there is no mention of experts establishing ground truth for a test set. The evaluation is primarily by the FDA reviewers against the characteristics of the predicate device.

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

Not Applicable / Not Provided: As no specific test set or clinical data requiring adjudication is presented in this summary.

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

Not Applicable: This device is a catheter, not an AI or imaging diagnostic device. Therefore, MRMC studies and AI assistance are not relevant to its regulatory submission.

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

Not Applicable: This device is a catheter, not an algorithm.

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

Not Applicable / Not Explicitly Stated: The "ground truth" for this 510(k) submission is effectively the established safety and effectiveness of the predicate device (Ultra Catheter Set for Sonohysterography from Lyco Enterprises, Inc.). The new device is considered acceptable if its characteristics align with this predicate, implying it will have similar safety and effectiveness.

8. The sample size for the training set

Not Applicable / Not Provided: There is no "training set" in the context of this catheter device. The device's design, materials, and manufacturing are based on established engineering principles and comparison to the predicate, not machine learning training.

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

Not Applicable / Not Provided: As there is no training set for this device.

Summary

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NOV 1 9 2001

KOI 3437 510(k) Summary As Required by 21 section 807.92 ( c )

1-Submitter Name: A & A Medical, Inc.
9370 Industrial Trace 2-Address:
- Alpharetta, GA 30004
(770) 343- 8400 3-Phone:
(770) 343- 8985 4-Fax:
Jay Mansour 5-Contact Person:
6-Date summary prepared: October 8tt, 2001

7-Device Trade or Proprietary Name: 5F SH Catheter

8-Device Common or usual name: Catheter for Sonohysterography

Cannula, Manipulator/Injector, Uterine 9-Device Classification Name:

10-Substantial Equivalency is claimed against the following device:

Ultra Catheter Set for Sonohysterography, from Lyco Enterprises, Inc. ●
11-Description of the Device:

The device is to be used by physicians in hospitals

The 5F SH catheter consists of two parts: a single lumen catheter and a semi-rigid introducing sheath.

The catheter is available in a 5 French diameter with a length of 32 cm. The distal end has a side port. The proximal end is fitted with a female luer-lock hub. The catheter is banded with a non-toxic ink 7 cm from the distal tip

The semi-rigid sheath has an internal diameter to allow movement over the catheter and a wall thickness sufficient to provide semi-rigid flexibility. The sheath is 17.5 cm long and flanged and rounded at the distal end to provide a non-traumatic surface to the tissues. The proximal end allows for temporary fixation over the proximal hub of the catheter.

12-Intended use of the device:

The SF SH Catheter 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 K001115
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 (DETAILED)

Image /page/2/Figure/1 description: This image is a flowchart that outlines the process for determining whether a new device is substantially equivalent to a marketed device. The flowchart starts with comparing the new device to a marketed device and proceeds through a series of questions about the device's intended use, technological characteristics, and potential impact on safety and effectiveness. The flowchart uses a series of yes/no questions to guide the user through the process, ultimately leading to a determination of whether the new device is substantially equivalent or not.

510(k) submissions compare new devices to marketed devices. FDA requests additional information in the relationship cen marketed and "predicate" (pe-Amendments or reclassified post-Amendments) devices is unclear. be
· This decision is normally based on descriptive information alone, but limited testing information is somelines required.

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

PAGE 3 of 3

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Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized symbol that resembles three wavy lines or a caduceus without the staff.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 9 2001

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

Re: K013437

Trade/Device Name: Sonohysterography Catheter, Model R65-946 Regulation Number: None Regulatory Class: Unclassified Product Code: 85 LKF Dated: October 8, 2001 Received: October 17, 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 notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Office of Compliance at one 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 Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Snogdon

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
Page 1 of 1

510(k) Number (if known):	K013437
Device Name:	SONOHYSTEROGRAPHY CATHETER (5 Fr) [R65-946]
Indications For Use:

THE SONOHYSTEROGRAPHY CATHETER (5 Fr) 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)

(Division Sign-Off)	Nancy Bralon
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number	K013437

Prescription Use (Per 21 CFR 801.109)	OR	Over-The-Counter Use (Optional Format 1-2-96)
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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.