The SIB Catheter consists of a 5 F balloon catheter with a single lumen polyurethane shaft with an end hole. The balloon inflates upon infusion of contrast media into the uterus. Increasing the infusion rate will cause the balloon to grow thereby occluding the cervical canal. Cessation of saline injection will cause the balloon to collapse.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "SIB Catheter." The submission aims to demonstrate substantial equivalence to a predicate device, not to prove clinical efficacy or performance through a traditional clinical study with detailed acceptance criteria as one might find for a novel therapeutic device or diagnostic algorithm.

Therefore, many of the requested categories for a study proving device acceptance criteria cannot be directly answered from the provided text, as this type of information is not typically included in a 510(k) for a device like a catheter demonstrating substantial equivalence. The "acceptance criteria" here refer more to meeting design and manufacturing specifications.

Here's an analysis based on the provided text, highlighting what can and cannot be answered:

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

Based on the provided text, there isn't a specific table of acceptance criteria with reported performance metrics in the way one would evaluate an AI algorithm or a diagnostic test. The acceptance criteria for a device like the SIB Catheter in a 510(k) context primarily revolve around demonstrating:

Substantial Equivalence: That the device is as safe and effective as a legally marketed predicate device.
Performance Requirements: That the device meets its design and functional specifications (e.g., balloon inflation, material integrity, sterility).

The text states:

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

This is a general statement of compliance, not a detailed breakdown of specific performance metrics or acceptance thresholds.

Acceptance Criteria (Implied from 510(k) Context)	Reported Device Performance (from text)
Safety & Effectiveness	"It was determined that the SIB Data Catheter performs safely and effectively."
Equivalency to Predicate Device	"The SIB Catheter is substantially equivalent to the predicate H/S Elliptosphere Catheter Set."
Meeting Performance Requirements	"Pre-clinical testing has been conducted to verify that the product meets the Performance performance requirements described."
Technological Characteristics	"The SIB Catheter has the same technological characteristics as the predicate device. The intended use, operating principle are identical."
Packaging and Sterilization	"The SIB Catheter is packaged and sterilized using the same materials and processes."

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

The text mentions "Pre-clinical testing" but does not specify the sample size, type of test set (e.g., in-vitro, animal, human), or data provenance. This is typical for a 510(k) focused on a relatively simple, non-novel device demonstrating substantial equivalence.

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. The text does not describe a study involving expert-established ground truth for a diagnostic assessment. The "ground truth" for this catheter's performance would relate to its physical and functional specifications (e.g., balloon integrity, material biocompatibility, flow rates), which are typically verified through engineering and bench testing, not expert consensus on diagnostic images.

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

Not applicable. No expert-based adjudication in a diagnostic context 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

Not applicable. This device is a catheter for contrast media delivery, not an AI algorithm or a diagnostic tool that would involve human readers or AI assistance.

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

Not applicable. This is not an algorithm, but a physical medical device.

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

For a device like the SIB Catheter, the "ground truth" effectively comes from engineering specifications, material science testing, and manufacturing quality control. For instance:

Balloon inflation capability: Verified against design specifications.
Lumen patency: Verified against design specifications.
Biocompatibility: Verified through standard testing (e.g., ISO 10993).
Sterility: Verified through validation of sterilization processes.

The text does not go into this level of detail, simply stating that "Pre-clinical testing has been conducted to verify that the product meets the Performance performance requirements described."

8. The sample size for the training set

Not applicable. This device is not an AI algorithm requiring a training set.

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

Not applicable. This device is not an AI algorithm.

Summary

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Attachment 4

510(k) Summary

and the security of the minister

and the considered to

DeviceDescription	Trade Name:	SIB Catheter
	Common Name:	Hysterosonography Catheter
	Classification Name:	Cannula, manipulator/injector, Uterine, ProductCode LKF
PredicateDevice	K013972, H/S Elliptosphere Catheter Set, 12/17/01
Date	April 17, 2002
Contact	Richard HettenbachVice President, Regulatory Affairs and Quality AssuranceAckrad Laboratories, Inc.70 Jackson DriveCranford, NJ 07016Tel: (908) 276-6390Fax: (908) 276-1895
Device	The SIB Catheter consists of a 5 F balloon catheter with a single lumenpolyurethane shaft with an end hole. The balloon inflates upon infusion ofcontrast media into the uterus. Increasing the infusion rate will cause theballoon to grow thereby occluding the cervical canal. Cessation of salineinjection will cause the balloon to collapse.
Intended Use	The SIB Catheter is intended for the delivery of diagnostic contrast mediaagents into the female reproductive tract for examination of the uterus
TechnologicalCharacteristics	The SIB Catheter has the same technological characteristicsas the predicate device. The intended use, operating principle areidentical. The SIB Catheter is packaged and sterilized using the samematerials and processes.

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

Conclusion The SIB Catheter is substantially equivalent to the predicate H/S Elliptosphere Catheter Set.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Richard Hettenbach Vice President, Regluatory Affairs/Quality Assurance ACKRAD Laboratories, Inc. 70 Jackson Drive CRANFORD NJ 07016

Re: K021272

Trade/Device Name: SIB Catheter Model 61-7005 Regulation Number: None Regulatory Class: Unclassified Product Code: 85 LKF Dated: April 17, 2002 Received: April 22, 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 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 Crozdon

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

210(k) Number

KO21272

SIB Catheter

Device Name

Indications for Use

The SIB Catheter is used for the delivery of diagnostic contrast media into the female reproductive tract for 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_

David A. Aycock

(Division Sign-Off) Division of Reproductive, Ab and Radiological Devices 02/272 510(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.