The ECHO-COAT™ Ultrasound Needle is indicated for use where improved visibility on ultrasound images is required compared to an uncoated needle. The coated needle also assumes the specific indications for use of the currently marketed uncoated needle, for example biopsy, amniocentesis, vascular access, aspiration, and drainage needles.

Device Description

STS Biopolymers, Inc. will purchase in bulk currently marketed needles designated by application (biopsy, aspiration, amniocentesis, etc.), needle type (spinal, Chiba, Franseen, other), needle gauge (11 to 30), and length (3 to 20 cm), and then apply a polymer coating. The coating, called ECHO-COAT™, is visible in ultrasound images, assisting with positioning. The coated needles will be repackaged as single-use devices, sterilized with EtO, and distributed commercially under the STS Biopolymers, Inc. name.

AI/ML Overview

The provided text, K983647, describes the ECHO-COAT™ Ultrasound Needles and their substantial equivalence to a predicate device. However, it does not contain the detailed study information regarding acceptance criteria and performance data that you've requested.

The document states:

"STS is providing performance data to demonstrate equivalence where necessary."
"STS Biopolymers, Inc. carried out performance testing on the ECHO-COAT™ Ultrasound Needles. This testing addressed the following issues: Sterilization, Package Integrity, Biocompatibility, Imaging Performance Testing. All of the results demonstrate substantial equivalence."

Crucially, the K983647 document summarizes that testing was done and performance was demonstrated, but it does not provide the specific acceptance criteria, the reported device performance against those criteria, sample sizes, ground truth establishment methods, or any details about multi-reader studies.

Therefore, I cannot fill out the requested table and answer many of your questions based solely on the provided input.

Based on the available information in K983647, here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

Cannot be provided. The document states that "performance testing" and "imaging performance testing" were done, and that "all of the results demonstrate substantial equivalence," but it does not specify the quantitative acceptance criteria or the measured performance values for the ECHO-COAT™ Ultrasound Needles.

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

Cannot be provided. The document mentions "performance testing" but does not detail the sample sizes used for any of the tests (Sterilization, Package Integrity, Biocompatibility, Imaging Performance Testing). It also does not specify the data provenance (country, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Cannot be provided. The document does not describe the establishment of a "ground truth" for a test set, nor does it mention the use of experts for this purpose, especially in the context of imaging performance. The "imaging performance testing" is mentioned as a general category.

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

Cannot be provided. No information on adjudication methods is present.

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

Cannot be provided. This K983647 submission is for an ultrasound needle with a coating for improved visibility, not an AI-powered diagnostic device. Therefore, an MRMC study with AI assistance would not be applicable or expected for this type of device.

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

N/A. This device is a physical medical instrument (an ultrasound needle), not an algorithm or software. Standalone performance testing would refer to direct measurement of the needle's physical and imaging properties. The document implies such testing was done under "Imaging Performance Testing" but provides no details.

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

Cannot be provided. The document does not specify how ground truth was established for "Imaging Performance Testing." Given the nature of the device, it would likely involve objective measures of visibility (e.g., contrast-to-noise ratio, depth of visibility in tissue phantoms) rather than clinical ground truth like pathology or outcomes data.

8. The sample size for the training set

N/A. This is not an AI/machine learning device, so there is no concept of a "training set."

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

N/A. As above, no training set, so no ground truth establishment for it.

Summary of what is known from K983647:

Device Name: ECHO-COAT™ Ultrasound Needles
Purpose: The polymer coating (ECHO-COAT™) improves visibility of the needles in ultrasound images, assisting with positioning.
Predicate Device: Disposable Chiba Biopsy Needle for Use with Ultrasound manufactured by Cook (K851957), as modified with the "EchoTip" for ultrasound imaging visibility.
Technological Characteristics: The coating is visible in ultrasound images, unlike the predicate which uses etching. This is identified as the key technological difference.
Testing Performed: Sterilization, Package Integrity, Biocompatibility, and Imaging Performance Testing.
Conclusion: All tests "demonstrate substantial equivalence."

To obtain the detailed information you requested, one would need to access the full submission documents, specifically the sections detailing the performance testing for the ECHO-COAT™ Ultrasound Needles. This 510(k) summary only provides a high-level overview.

Summary

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K 983647

510(k) Summary

ECHO-COAT™ Ultrasound Needles

Common/Classification Name: Manual Surgical Instrument, 21 CFR 878.4800

STS Biopolymers, Inc. 336 Summit Point Drive Henrietta, NY 14467

Contact: Michael Violante, Prepared: October 12, 1998

LEGALLY MARKETED PREDICATE DEVICES A.

The ECHO-COAT™ Ultrasound Needles are substantially equivalent to the Disposable Chiba Biopsy Needle for Use with Ultrasound manufactured by Cook (K851957), as modified with the "EchoTip" for ultrasound imaging visibility.

B. DEVICE DESCRIPTION

C. INTENDED USE

ECHO-COAT™ Ultrasound Needles are easily visualized on ultrasound images produced by currently available ultrasound imaging devices operating between 1 and 20 MHz. The needles are biocompatible when used according to their intended use. The specific indications for use for the needles purchased for coating will be assumed for the coated product.

D. SUBSTANTIAL EQUIVALENCE SUMMARY

The ECHO-COAT™ Ultrasound Needles have similar, but not identical, technological characteristics as the predicate devices. The

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could affect safety and effectiveness, e.g., the differences direronooo ooans of the polymer coating as compared to stainless blocomputibility of e o w characteristics do not raise new types of steen. However, and effectiveness questions and there are readily available Salety and offectively biocompatibility tests) to assess the effects of selections tools (significs (the material). STS is providing performance data to demonstrate equivalence where necessary.

TECHNOLOGICAL CHARACTERISTICS E.

The needles that are purchased for coating by STS Biopolymers, Inc. The neoules that a same technological characteristics as the coated product that will be marketed by STS Biopolymers, Inc.. The additional product that will be coating is new, but it does not raise new types of safety and effectiveness questions. Biocompatibility is required of all needles and can be assured through testing using accepted standards. Ultrasound visibility is obtained through the new coating rather than by etching the surface as in the predicate device. However, there are readily available methods for determining ultrasound visibility also. Through the presentation of the resulting performance data, STS Biopolymers, Inc. has demonstrated that its proposed product is substantially equivalent to the predicate device.

TESTING F.

STS Biopolymers, Inc. carried out performance testing on the ECHO-COAT™ Ultrasound Needles. This testing addressed the following issues:

Sterilization (1)
(2) Package Integrity
Biocompatibility (3)
Imaging Performance Testing (4)

All of the results demonstrate substantial equivalence.

G. CONCLUSIONS

This pre-market submission has demonstrated Substantial Equivalence as defined and understood in the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often used as a symbol of medicine. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 20 1999

T. Whit Athey, Ph.D. Senior Consultant C.L. McIntosh & Associates, Inc. 12300 Twinbrook Parkway, Suite 625 Rockville, Maryland 20852

K983647 Re:

Trade Name: ECHO-COAT™ Ultrasound Needle Regulatory Class: I Product Code: MJG Dated: October 16, 1998 Received: October 16, 1998

Dear Dr. Athey:

We have reviewed your Section 510(k) notification of intent to market the device referenced we nave reviewed your bootion by o(x) = (x) = (x) = (x) = (x) = = = = = indications for above and we have decembined avices marketed in interstate commerce prior to use stated in the enerosure) to actives he Medical Device Amendments, or to devices that May 20, 1970, the chaouncent auto of with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosment Act (Act). " Tournaly, arefere) is provisions of the Act include requirements for provisions of the Free Frite genevices, 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 (1 remarket Approval), it they over can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the I urs 600 to 699. In a facturing Practice requirement, as set forth in the Quality System Carrent Good Friend Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify through portodio (QD) inspecially with the GMP regulation may result in regulatory such assumptions. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does I oderal Negation you might have under sections 531 through 542 of the Act for not any other the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - T. Whit Athey, Ph.D.

This letter will allow you to begin marketing your device as described in your 510(k) I mis letter witification. The FDA finding of substantial equivalence of your device to a prendared notificated 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) 594-4595. 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 807.97). Other 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/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

ECHO-COATTM Ultrasound Needle Device Name:

Indications For Use:

(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 _

A coole
Division Sign-Off

Regulation Number and Section

§ 878.4800 Manual surgical instrument for general use.

(a)
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.