The Carbon Medical Technologies Injection Needle is an accessory for currently marketed endoscopes to allow delivery of injectable materials into tissues during endoscopic procedures.

Device Description

The Carbon Medical Injection Needle consists of a stainless steel needle attached to two or more luer lock hubs. A standard syringe can be attached to the hubs for injection of materials through the lumen of the needle into tissue. Multiple needle lengths and gauges are available.

AI/ML Overview

The provided text describes a 510(k) summary for the Carbon Medical Technologies Injection Needle. This submission focuses on establishing substantial equivalence to predicate devices based on technological characteristics, biocompatibility, and bench testing. It does not contain information about a study that assesses performance against specific acceptance criteria for diagnostic or AI-driven devices. Therefore, I cannot provide the detailed information requested in your prompt.

The document states:
"Technological Characteristics and Performance
The technological characteristics are substantially equivalent to the predicate devices. Biocompatibility and bench testing has demonstrated that the device is safe and effective and that its performance is substantially equivalent to the predicate device."

This indicates that the submission relied on demonstrating that the new device's design and materials are similar to previously cleared devices, and that standard engineering tests (bench testing) confirmed its basic function and safety (biocompatibility). There is no mention of a clinical study, performance metrics like sensitivity or specificity, or any evaluation involving human readers or AI.

To answer your specific questions in the context of this document:

A table of acceptance criteria and the reported device performance: Not applicable. The document does not define specific performance acceptance criteria or report performance metrics (e.g., accuracy, sensitivity, specificity) for comparison. The performance claim is general substantial equivalence to predicate devices based on technological characteristics and bench testing.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. No test set involving patient data is described. The evaluation was based on bench testing and characterization of technological similarity.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth based on expert review is mentioned, as there was no study involving patient data or diagnostic interpretation.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No adjudication method 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: Not applicable. This device is an injection needle, not an AI or diagnostic imaging device. No MRMC study was performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. Ground truth for diagnostic performance is not relevant to this device's submission. The "ground truth" for this submission would be the established performance and safety of the predicate devices, which the new device is claimed to be substantially equivalent to, based on bench testing.
The sample size for the training set: Not applicable. No training set is mentioned as this is not an AI/ML device.
How the ground truth for the training set was established: Not applicable. No training set or ground truth for it is mentioned.

In summary, the provided 510(k) summary for the Carbon Medical Technologies Injection Needle is for a hardware medical device (an injection needle) and relies on demonstrating substantial equivalence to pre-existing predicate devices through technological characteristics, biocompatibility, and bench testing, rather than performance studies requiring the criteria you've outlined, which are typical for diagnostic or AI-powered devices.

Summary

{0}------------------------------------------------

510(k) Summary

K030451

Submitter's Name, Address, and Date of Submission

Robert W. Johnson Vice President of Regulatory, Clinical and Quality Assurance Carbon Medical Technologies, Inc. 1290 Hammond Road St. Paul, MN 55110 651-762-2146 Phone: Fax: 651-407-1975

Submitted: February 7, 2003

Device Name

Trade Name:	Carbon Medical Technologies Injection Needle
Classification:	Class II
Classification Name:	Endoscope and/or Accessories, 21 CFR 876.1500
Common/Usual Name:	Endoscopic Injection Needles
Predicate Device:	Advanced UroScience, Inc. Injection Needle [(K)002323]Ocean Medical Products Single Wall Introducer Needle[(K)843719]

Intended Use

The Carbon Medical Injection Needle is an accessory to currently marketed endoscopes to allow delivery of injectable materials into tissues during an endoscopic procedure.

Device Description

Technological Characteristics and Performance

The technological characteristics are substantially equivalent to the predicate devices. Biocompatibility and bench testing has demonstrated that the device is safe and effective and that its performance is substantially equivalent to the predicate device.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird with three stylized human profiles incorporated into its design. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 3 0 2003

Mr. Robert W. Johnson Vice President, Regulatory and Clinical Affairs and Quality Assurance Carbon Medical Technologies, Inc. 1290 Hammond Road ST PAUL MN 55110-5867

Re: K030451

Trade/Device Name: Carbon Medical Technologies Injection Needle Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: 78 FBK Dated: February 7, 2003 Received: February 11, 2003

Dear Mr. Johnson:

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

{2}------------------------------------------------

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 C Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Indications for Use Statement

K030451

510(k) Number (if known)

Carbon Medical Technologies Injection Needle Device Name

Indications for Use

The Carbon Medical Technologies Injection Needle is an accessory for currently marketed endoscopes to allow delivery of injectable materials into tissues during endoscopic procedures.

(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 B. Legron

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number.

(Optimal Format 1-2-96)

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.