The Confidence Cement Delivery System is intended for percutaneous delivery of Confidence bone cement, which is indicated for fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebrai compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancer, myeloma).

Device Description

The Confidence Fenestrated Introducer Needle, a part of the Confidence Cement Delivery System, is combined of a cannula and a stylet. The cannula has a diamond-shape closed distal tip, and has numerous holes located around its distal section.

AI/ML Overview

This document, K063067, is a 510(k) Summary for the Confidence Fenestrated Introducer Needle, a component of the Confidence Bone Cement Delivery System. This submission is for a medical device, not an AI/ML powered device, therefore the information requested cannot be fully extracted.

Here's a breakdown of what can be inferred and what cannot based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable: This document describes a physical medical device (an introducer needle) and not an AI/ML system. Therefore, there are no "acceptance criteria" or "reported device performance" in terms of algorithmic metrics (like accuracy, sensitivity, specificity) that would be relevant to an AI/ML device. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device based on design, materials, technological characteristics, and principles of operation.

2. Sample size used for the test set and the data provenance

Not applicable: No test set in the context of AI/ML validation is mentioned. This is a physical device.

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

Not applicable: No ground truth establishment for a test set is mentioned.

4. Adjudication method for the test set

Not applicable: No adjudication method is mentioned.

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: No MRMC study is mentioned. This is a physical device, not an AI system designed to assist human readers.

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

Not applicable: No standalone algorithm performance is mentioned.

7. The type of ground truth used

Not applicable: As this is a physical device, the concept of "ground truth" as it applies to AI/ML model training or validation does not apply. The validation for this type of device typically involves demonstrating manufacturing and functional equivalence to a predicate device, as well as adherence to relevant standards, not a comparison against expert-labeled data.

8. The sample size for the training set

Not applicable: No training set is mentioned as this is a physical medical device, not an AI/ML product.

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

Not applicable: No training set or associated ground truth is mentioned.

Summary of available information:

Device Name: Confidence Fenestrated Introducer Needle
Intended Use: For percutaneous delivery of bone cement during vertebroplasty/kyphoplasty procedures.
Predicate Devices: Confidence High Viscosity Bone Cements (K060300, K062424)
Substantial Equivalence Claim: Based on intended use, design, materials, technological characteristics, and principles of operation to the predicate device.

To reiterate, the provided document pertains to the regulatory clearance of a physical medical instrument and does not contain the kind of information relevant to the validation of an AI/ML powered medical device.

Summary

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K063067 p. 1/2

510(K) Summary

Nov - 3 2006

Disc-O-Tech Medical Technologies Ltd.

Confidence Bone Cement Delivery System - Fenestrated Introducer Needle

Submitter Name

Disc-O-Tech Medical Technologies Ltd. 11 Ha'Hoshlim St., Herzliya 46724, Israel

Contact Person

Yael Rubin Disc=O=Tech Medical Technologies Ltd. 11 Ha'Hoshlim St., Herzliya 46724, Israel Tel: 972 9 9511511, Fax: 972 9 9548939

1. Jonathan S. Kahan, Esq. Hogan & Hartson L.L.P 555 Thirteenth Street, NW, Washington, DC 20004 Tel: 202 637 5794, Fax: 202 637 5910

Date Prepared

October 2006

Trade/Proprietary Name

Confidence Fenestrated Introducer Needle

Common Name

Needle

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KC63067 p 2/2

Disc-O-Tech Medical Technologies Ltd. Confidence Fenestrated Introducer Needle Special 510(k)

Classification Name

Orthopedic Manual Surgical Instrument

Predicate Devices

Confidence High Viscosity Bone Cements (K060300, K062424)

Intended Use

The Confidence Bone Cement Delivery System is intended for percutaneous delivery of bone cement, during vertebroplasty/kyphoplasty procedures

System Description

Substantial Equivalence

In general, the Confidence Fenestrated Introducer Needle intended use, design, materials, technological characteristics, and principles of operation are substantially equivalent to those of the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Disco-O-Tech Medical Technologies, Ltd. % Hogan & Hartson, L.L.P Mr. Jonathan S. Kahan, Esq. 555 Thirteenth Street, Northwest Washington, District of Columbia 20004

3 2006

Rc: K063067

Trade/Device Name: Confidence Cement Delivery System Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: NDN Dated: October 4, 2006 Received: October 6, 2006

Dear Mr. Kahan:

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 adultcration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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Page 2 - Mr. Jonathan S. Kahan, Esq.

This letter will allow you to begin marketing your device as described in your Section 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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

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

Enclosure

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Indication for Use

510(K) Number (if known): KOG3067

Device Name: Confidence Cement Delivery System

Indication for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

AND/OR

CDRH, Office of Device Evaluation (ODE) Concurrence o

Styts Klude
Division Sign Off

Division of General, Restorative, and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.

(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”