INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETER by ACKRAD LABORATORIES

The Tampa Hysterosonography set will consist of two parts: a single lumen catheter and a semi-rigid introducing sheath. The catheter will be available in a 5-French diameter with a length of 33 cm. The distal end will have either a side port or end port. The proximal end will be fitted with a female luer-lock hub. The catheter will be banded with non-toxic ink 7 cm. from the distal tip. The semi-rigid sheath has an internal diameter to allow easy movement over the catheter and a wall thickness sufficient to provide semi-rigid flexibility. It is 16 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

This 510(k) summary describes a device focused on mechanical characteristics and equivalence, not algorithmic performance. Therefore, many of the requested categories related to AI/algorithm performance and clinical study design for such algorithms are not applicable.

Here's the information that can be extracted or deduced from the provided text:

Acceptance Criteria and Device Performance Study

Acceptance Criteria	Reported Device Performance	Study Type
Substantial Equivalence: Materials, construction, indications for use, and technological characteristics are equivalent to predicate devices, ensuring similar safety and effectiveness.	The materials and construction of the Tampa Hysterosonography Set are identical to those of the approved predicate device, K940176/A (Ackrad IUI Catheter Set), with the exception of catheter and placement sheath lengths. Indications for use are the same ("Injection of saline in the examination of the uterus using ultrasound techniques").	Equivalence study based on comparison to predicate devices and existing clinical data for the predicate.
Safety and Effectiveness: Demonstrated through clinical experience with predicate devices.	Procedures for hysterosonography using the predicate IUI Set demonstrate the safety and effectiveness of that product for hysterosonography.	Clinical results of predicate device (retrospective)
Biocompatibility: Equivalent to predicate device.	Equivalent to the predicate IUI Set, as material and location of use are identical.	Material-based comparison to predicate device.

Detailed Analysis of Requested Information:

A table of acceptance criteria and the reported device performance
- See table above. The core acceptance criterion is "substantial equivalence" to predicate devices in terms of materials, construction, indications for use, safety, and effectiveness. The reported performance confirms these equivalences.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not applicable. This is not an AI/algorithmic device requiring a dedicated test set with performance metrics like accuracy, sensitivity, specificity, etc. The "performance data" refers to the equivalence to predicate devices and their established clinical use.
- Data Provenance: The "Clinical results" section refers to "Procedures for hysterosonography using the predicate IUI Set." This implies retrospective clinical experience with the predicate device(s). No specific country of origin is mentioned.
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. There is no "ground truth" establishment in the context of an algorithmic test set described here. The "ground truth" for the predicate device's safety and effectiveness would have been established through its own clinical trials and usage, but details are not provided here beyond general mention.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set requiring adjudication is described.
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 physical medical instrument (catheter set) used for a procedure (hysterosonography), not an AI algorithm. Therefore, an MRMC study related to AI assistance is not relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the predicate device's safety and effectiveness, the "ground truth" would likely be derived from clinical outcomes data observed during hysterosonography procedures. However, the document only broadly states that clinical results "demonstrate the safety and effectiveness."
The sample size for the training set
- Not applicable. There is no AI algorithm being trained.
How the ground truth for the training set was established
- Not applicable. There is no AI algorithm being trained.

Summary

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ACKRAD LABORATORIES · 70 Jackson drive · cranford, n.j. 07016 · (908) 2

APR - 9 1997

510(k) Summary

REQUIRED INFORMATION A.

1. Submitted by Ackrad Laboratories, Inc., 70 Jackson Drive, Cranford, NJ 07016, Telephone No. (908) 276-6390, Fax No. (908) 276-1895, Contact person: Bernard Ackerman, Ph.D. Date: February 3, 1997
1. Device name Tampa Hysterosonography Set

Predicate Devices 3. Ackrad Intrauterine Insemination Set, K940176/A a.

"Goldstein" Sonohysterography Catheter. b.
1. Description of the device (see exhibit 2)

The Tampa Hysterosonography set will consist of two parts: a single lumen catheter and a semi-rigid introducing sheath.

The catheter will be available in a 5-French diameter with The distal end will have either a side a length of 33 cm. port or end port. The proximal end will be fitted with a female luer-lock hub. The catheter will be banded with non-toxic ink 7 cm. from the distal tip.

The semi-rigid sheath has an internal diameter to allow easy movement over the catheter and a wall thickness sufficient to provide semi-rigid flexibility. It is 16 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.

1. Indication for use
  Injection of saline in the examination of the uterus using ultrasound techniques.

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K970492

1. Technical Characteristics
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The materials and construction of the Tampa Hysterosonography Set are identical to those of the approved predicate device, K940176/A with the exception of the lengths of the catheter and placement sheath.

PERFORMANCE DATA B.
- 1. Non-clinical tests Not applicable
- 1. Clinical results Procedures for hysterosonography using the predicate IUI Set demonstrate the safety and effectiveness of that product for hysterosonography. (See exhibits 5A and 5B)
- 1. Biocompatibility Equivalent to the predicate IUI Set , as material and location of use are identical.
CONCLUSION OF SAFETY AND EFFECTIVENESS C.

The above description, indications for use, technological characteristics, and clinical results demonstrate that the Tampa Hysterosonography Set is substantially equivalent in safety and effectiveness to the predicate devices, the Ackrad IUI Catheter Set, K940176/A and the Goldstein Sonohysterograhy Catheter.

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.