The device features a simple flux metallic needle, 30 cm in useful length, 17 gauge in outside diameter and 18 gauge in inside diameter, with double chambered point and echogenic distal tip on two centimeters for easier ultrasound guidance.

The needle is placed in a teflon packing tubing for protection. A teflon-cast catheter carries the aspirated follicular fluid to a 30 ml round-bottomed vial fitted with a screw-cap, or to a 30 ml round-bottomed vial fitted with a flexible cap (model HOC Set 2).

The model with a three-way valve set between the puncture needle and the collecting vial allows suction and rinsing of the follicles in turn.

Packaging: Disposable device in single unit blister packaging. Irradiation sterilized. Available in 5 unit packs. H.O.C. vials are also sold alone by 50 units.

O.P.S. Oocyte Puncture Set™ Needle: 30 cm; O.D. 17 gauge, I.D. 18 gauge, echogenic tip

The device features a simple flux metallic needle, 30 cm in useful length and 17 gauge in outer diameter and 18 gauge in inside diameter, with doublechambered point and echogenic distal tip on two centimeters for easier ultrasound guidance. The device must be connected to an irradiation sterilized Falcon tube.

The needle is placed in a teflon packing tubing for protection. A teflon-cast catheter carries the aspirated follicular fluid to a Falcon tube.

Packaging: Disposable device in single unit blister packaging. Irradiation sterilized. Available in 5 unit packs.

Luer-lock Needle for Ovum recovery Needle: 25 cm or 30 cm; O.D. 17 gauge, echogenic tip; I.D. 18 gauge

Simple flux steel needle, 17 gauge in outside diameter and 18 gauge in inside diameter, with double-chambered point and echogenic distal tip on two centimeters for easier ultrasound guidance.

Two sizes: 25 cm or 30 cm long.

The needle has a Luer-lock to attach a syringe, and a green plastic inner madrel. The needle is placed in a Teflon packing tubing for protection. Packaging: Disposable device in single unit sealed bag. Irradiation sterilized. Available in 10 unit packs.

AI/ML Overview

This submission describes the "PRODIMED Assisted Reproduction Needles" which include "HOC SET," "OPS," and "Luer-lock Needle for Ovum recovery."

Here's an analysis of the provided text in relation to acceptance criteria and performance studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state any quantitative acceptance criteria or present a table of reported device performance metrics. This is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results against pre-defined criteria.

The "Function of Devices/Significant Physical Characteristics of Device" section describes the intended functionality qualitatively:

Device Function/Characteristic	Desired Outcome (Implicit Acceptance Criteria)	Reported Device Performance
Ova Recovery	Safe and effective recovery of maximum ova.	Achieves safe and effective recovery of maximum ova.
Traumatic Handling	Elimination of risks of traumatic handling detrimental to zona pellucida integrity.	Eliminates risks of traumatic handling of the ovum that would be detrimental to zona pellucida integrity.
Operating Conditions	Ensuring optimal operating conditions for ovum conservation and better fertilization rate.	Insures optimal operating conditions for ovum conservation and better fertilization rate.
Luer-lock Needle Use	Acts as a laparoscopic or ultrasonographic ovum recovery device.	Acts as a laparoscopic or ultrasonographic ovum recovery device (transvesical, transvaginal, periurethral or endovaginal).

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

The document does not provide any information regarding a test set sample size or data provenance. The 510(k) summary focuses on device description and intended use, not clinical study data for acceptance.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

The document does not describe any expert-established ground truth or the qualifications of such experts. This type of information would typically be found in a clinical study report, which is not provided here.

4. Adjudication Method:

Since no expert ground truth establishment or clinical study is described, there is no mention of an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The document does not mention any MRMC comparative effectiveness study, nor does it provide information on the effect size of human readers with vs. without AI assistance. The device described is a physical medical instrument (needles), not an AI-powered diagnostic tool.

6. Standalone (Algorithm Only) Performance:

As the device is a physical medical instrument and not an algorithm or AI system, the concept of standalone algorithm performance does not apply and is not mentioned.

7. Type of Ground Truth Used:

The document does not specify any type of ground truth used, as it does not present data from studies requiring a ground truth.

8. Sample Size for the Training Set:

The submission does not mention any training set or its sample size. The device is a physical product, not a machine learning model.

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

Since there is no training set and no machine learning model, the method for establishing ground truth for a training set is not applicable and therefore not described.

In summary, this 510(k) submission is for a physical medical device (assisted reproduction needles) and seeks clearance based on substantial equivalence to a predicate device. It does not contain the kind of detailed performance study data, acceptance criteria, or ground truth establishment information that would be present for a diagnostic or AI-driven medical device requiring extensive clinical validation against specific performance metrics. The "acceptance criteria" can only be implicitly inferred from the description of the device's function.

Summary

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K990913

510(K) Summary

March 9, 1999

PRODIMED Laboratories c/o Washington Regulatory Services Randolph L. Cooke 23 Welisewitz Road Ringoes, NJ 08551 609-466-0510 Fax 609-466-4443

2) DEVICE NAME:

Proprietary Names:

HOC SET with valve HOC SET without valve HOC SET with valve - Soft plug HOC SET without valve - Soft plug

OPS without valve OPS with valve OPS double lumen

Luer Lock Needle 30 cm Luer Lock Needle 25 cm or any specified length

Common Name: Assisted Reproduction Needles

Classification Name: Assisted Reproduction catheters are classified as Class II at 21 CFR 884.6100. The product code is 85 MQE.

IDENTIFICATION: These devies have been down classified FR Vol 63, No. 175 September 10, 1998. Effective date: October 13, 1998.

4) DESCRIPTION OF DEVICE:

H.O.C. Set™ Hazout oocyte collector with or without valve Needle: 30 cm; O.D. 17 gauge, I.D. 18 gauge, echogenic tip Optional: 3-way valve

こ

The device features a simple flux metallic needle, 30 cm in useful length, 17 gauge in outside diameter and 18 gauge in inside diameter, with double

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chambered point and echogenic distal tip on two centimeters for easier ultrasound guidance.

The model with a three-way valve set between the puncture needle and the collecting vial allows suction and rinsing of the follicles in turn.

Packaging: Disposable device in single unit blister packaging. Irradiation sterilized. Available in 5 unit packs. H.O.C. vials are also sold alone by 50 units.

O.P.S. Oocyte Puncture Set™ Needle: 30 cm; O.D. 17 gauge, I.D. 18 gauge, echogenic tip

The needle is placed in a teflon packing tubing for protection. A teflon-cast catheter carries the aspirated follicular fluid to a Falcon tube.

Packaging: Disposable device in single unit blister packaging. Irradiation sterilized. Available in 5 unit packs.

Luer-lock Needle for Ovum recovery Needle: 25 cm or 30 cm; O.D. 17 gauge, echogenic tip; I.D. 18 gauge

Simple flux steel needle, 17 gauge in outside diameter and 18 gauge in inside diameter, with double-chambered point and echogenic distal tip on two centimeters for easier ultrasound guidance.

Two sizes: 25 cm or 30 cm long.

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Function of Devices/Significant Physical Characteristics of Device:

Both the H.O.C. Set™ (Hazout oocyte collector, with or without a valve) and the O.P.S. Oocyte Puncture Set™ procedures achieve a safe and effective recovery of a maximum ova, eliminating the risks of traumatic handling of the ovum that would be detrimental to zona pellucida integrity, thus insuring optimal operating conditions for ovum conservation and better fertilization rate.

The Luer-lock Needle for ovum recovery acts as a laparscopic or ultrasonographic ovum recovery device (transvesical, transvaginal, periurethral or endovaginal).

Device Design/ Material Used/ Physical Properties:

HOC SET:
Device Part	Material Used
Needle	Metal
Fitting	Polyamide
Collect tube
Vacuum tube	Polyether amide
Plug	Polyethylen
Tape	Polycarbonate
Collect ube	Butadien styren
OPS SET:
Device Part	Material Used
Needle	Metal
Fitting	Polyamide
Collect tube
Vacuum tube	Polyetreamid
Plug
Tape	Polycarbonate
Luer-lock Needles:
Device Part	Material Used
Needle	Metal
Fitting	Polyamide
Mandrel	Polyamide

5) STATEMENT OF INTENDED USED

These devices are used to introduce or remove gametres, zygotes(s), preembryo)s) and/or embryo(s) into or from the body.

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HOC SET with valve HOC SET without valve HOC SET with valve – Soft plug HOC SET without valve – Soft plug

OPS without valve OPS with valve OPS double lumen

Luer Lock Needle 30 cm Luer Lock Needle 25 cm or any specified length

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Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

JUN 8 1999 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

PRODIMED Laboratories c/o Washington Regulatory Services Mr. Randolph L. Cooke 23 Welisewitz Road Ringoes, N.J. 08551

Re: K990913

PRODIMED Assisted Reproduction Needles Dated: March 11, 1999 Received: March 18, 1999 Regulatory Class: II 21 CFR §884.6100/Procode: 85 MQE

Dear Mr. Cooke:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 pror 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations. Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 requilation entitled. "Misbranding by reference to premarket notification"(21 CFR 807.97). Qther general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

[signature]

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) number (if known)_K990913

DEVICE NAME: Prodimed Assisted Reproduction Needles

INDICATIONS FOR USE:

These devices are used to introduce or remove gametres, zygotes(s), preembryo)s) and/or embryo(s) into or from the body.

HOC SET with valve HOC SET without valve HOC SET with valve - Soft plug HOC SET without valve - Soft plug

OPS without valve OPS with valve OPS double lumen

Luer Lock Needle 30 cm Luer Lock Needle 25 cm or any specified

(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 CFE 801.109

Over-The Counter-Use_______ (Options Format 1-2-96)

Ra-Pales

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Dev 510(k) Number

Regulation Number and Section

§ 884.6100 Assisted reproduction needles.

(a)
Identification. Assisted reproduction needles are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to obtain gametes from the body or introduce gametes, zygote(s), preembryo(s) and/or embryo(s) into the body. This generic type of device may include a single or double lumen needle and component parts, including needle guides, such as those used with ultrasound.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).