The H/S Catheter Set is used for the delivery of diagnostic contrast media agents in the female reproductive tract for examination of the uterus and fallopian tubes.

Device Description

The H/S Catheter Set can be used for conducting either Hysterosalpingography (examination of the uterus and fallopian tubes using x-rays) or Hysterosonography (examination of the uterus and fallopian tubes using ultrasound sonography). All components are provided sterile for single use only.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the H/S Catheter Set:

The provided document (K020951) is a 510(k) Pre-market Notification for a medical device. These types of submissions typically focus on demonstrating substantial equivalence to a legally marketed predicate device, rather than extensive clinical efficacy studies with specific performance metrics and acceptance criteria as might be seen for novel devices or PMAs.

Based on the information provided, there are no explicit, quantifiable acceptance criteria or detailed study results for device performance as requested in the prompt. The submission primarily relies on demonstrating that the H/S Catheter Set is "substantially equivalent" to a predicate device.

Here's an attempt to answer the questions based on the available information:

A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
(Not explicitly stated in the document as quantifiable performance metrics for efficacy or safety)	"Pre-clinical testing has been conducted to verify that the product meets the Performance performance requirements described. It was determined that the H/S Data Catheter Set performs safely and effectively."
Substantial Equivalence to predicate device (Modified Hysterosalpingography Set K953034)	"The H/S Catheter Set has the same technological characteristics as the predicate device. The intended use, operating principle are identical. The H/S Catheter Set incorporates the same product design and is packaged and sterilized using the same materials and processes." "The H/S Catheter Set is substantially equivalent to the predicate Modified Hysterosalpingography Set."

Note: The document states "Pre-clinical testing has been conducted to verify that the product meets the Performance performance requirements described." However, these specific performance requirements are not described or quantified in the provided text. The "performance requirements" likely refer to bench testing for material compatibility, strength, sterility, etc., to ensure it functions similarly to the predicate, rather than clinical efficacy metrics.

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The document mentions "Pre-clinical testing," which typically refers to lab-based or bench testing, not patient data in the context of device performance.
- Data Provenance: Not specified. Given it's pre-clinical testing, it would likely be internal lab data, not patient data from a specific country.
- Retrospective or Prospective: Not applicable as it refers to pre-clinical testing, not patient studies.
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. The document does not describe a clinical study requiring expert-established ground truth. The "ground truth" for pre-clinical testing would be engineering specifications and test standards.
Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. No clinical adjudication is mentioned.
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

No. This device is a catheter set, not an AI or imaging interpretation device. Therefore, an MRMC study is not relevant or mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a catheter set, not a standalone algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the "pre-clinical testing" mentioned, the ground truth would likely be based on engineering specifications, material standards, and functional requirements applicable to the device's design and intended use, demonstrating equivalence to the predicate. No clinical outcomes data or expert consensus on clinical findings is discussed.
The sample size for the training set

Not applicable. This device is a catheter set, and the submission does not mention machine learning or AI requiring a training set.
How the ground truth for the training set was established

Not applicable. This device is a catheter set, not an AI/ML device.

Summary

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K020951
Page 1 of 2

APR 1 6 2002

Attachment 4

510(k) Summary

DeviceDescription	Trade Name:	H/S Catheter Set
	Common Name:	Hysterosalpingography or HysterosonographyCatheter
		Classification Name: Cannula, manipulator/injector, Uterine, ProductCode LKF
PredicateDevice		Modified Hysterosalpingography Set K953034, 8/29/95
Date	March 13, 2002
Contact	Richard HettenbachVice President, Regulatory Affairs and Quality AssuranceAckrad Laboratories, Inc.70 Jackson DriveCranford, NJ 07016Tel: (908) 276-6390Fax: (908) 276-1895
DeviceDescription	The H/S Catheter Set can be used for conducting eitherHysterosalpingography (examination of the uterus and fallopian tubesusing x-rays) or Hysterosonography (examination of the uterus andfallopian tubes using ultrasound sonography). All components areprovided sterile for single use only.
TechnologicalCharacteristics	The H/S Catheter Set has the same technologicalcharacteristics as the predicate device. The intended use, operatingprinciple are identical. The H/S Catheter Set incorporates the sameproduct design and is packaged and sterilized using the same materials andprocesses.

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K020951
Page 2 of 2

Pre-clinical testing has been conducted to verify that the product meets the Performance performance requirements described. It was determined that the H/S Data Catheter Set performs safely and effectively.

Conclusion

The H/S Catheter Set is substantially equivalent to the predicate Modified Hysterosalpingography Set.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/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 positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circle. The text is in all capital letters and is arranged to follow the curve of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 6 2002

Mr. Richard Hettenbach Vice President, Regulatory Affairs and Quality Assurance Ackrad Laboratories 70 Jackson Drive CRANFORD NJ 07016

Re: K020951

Trade/Device Name: H/S Catheter Set, (5F) Model61-5005, and (7F) Model 61-5007 Regulation Number: None Regulatory Class: Unclassified Product Code: 85 LKF Dated: March 13, 2002 Received: March 25, 2002

Dear Mr. Hettenbach:

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 nredicate 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. 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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Attachment 2

Indications for Use Statement

510(k) Number

K020951

Device Name

H/S Catheter Set

Indications for Use

The H/S Catheter Set is used for the delivery of diagnostic contrast media agents in the female reproductive tract for examination of the uterus and fallopian tubes.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The Counter Use

David L. Ingram

Sign-Off) le Andominal

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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.