The SKy System is intended for use as a conventional bone tamp for the reduction of fractures and/or creation of a void in cancellous bone in the spine, hand, tibia, radius and calcaneus.

Device Description

The SKy System consists of the following components:

√ Expandable Tube a tube-like component, mounted on a delivery system. Inserted into the bone in reduced 5-mm diameter configuration and expanded within the bone.
Delivery System used for the insertion, expansion, and retrieval of the expandable tube.
V Instrumentation Set a set of accessories to assist in insertion and location of the device.

AI/ML Overview

This 510(k) summary (K034037) for the SKy Bone Expander System primarily focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed information regarding acceptance criteria, performance studies, or quantitative results often found in submissions for novel or higher-risk devices.

Therefore, many of the requested sections cannot be fully populated from the provided text.

Here's an analysis based on the available information:

Acceptance Criteria and Device Performance

The document does not explicitly state acceptance criteria or a reported device performance table. The submission is a 510(k) seeking substantial equivalence, which implies that the device's performance is expected to be "as safe and effective as, and performs as well as or better than" the predicate devices. Performance is likely demonstrated through substantial equivalence arguments and engineering testing rather than a clinical study with stated acceptance criteria.

Study Information

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated in the provided text. For a 510(k) based on substantial equivalence, acceptance criteria would typically relate to mechanical performance, biocompatibility, sterilization, and sometimes clinical equivalence to predicate devices.
Reported Device Performance: Not explicitly reported in a quantitative table within the provided text. The document states similarities to the predicate device in terms of intended use, operating principles, design principles, materials, packaging, and sterilization methods.

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

The provided text does not describe a clinical "test set" with a specific sample size. The substantial equivalence argument relies on comparing the new device to previously cleared predicate devices.
Data Provenance: Not applicable in the context of a clinical test set in this document. The manufacturer is Disc-O-Tech Medical Technologies Ltd., based in Herzliya, Israel.

3. 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. The document does not describe a clinical study requiring ground truth establishment by experts.

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

Not applicable. The document does not describe a clinical study requiring adjudication.

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. The device (SKy Bone Expander System) is a physical surgical implant/instrument, not an AI-assisted diagnostic or therapeutic tool.

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

Not applicable. The device is a physical surgical implant/instrument, not an algorithm.

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

Not applicable. The document does not describe a study involving ground truth in a clinical context. Substantial equivalence for this type of device is typically demonstrated through engineering testing (e.g., mechanical strength, fatigue), biocompatibility testing, and comparison of design features and materials to predicate devices.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device.

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

Not applicable. This is not an AI/machine learning device.

Summary of available information regarding the device and its clearance:

Device Name: SKy Bone Expander System (SKy System)
Applicant: Disc-O-Tech Medical Technologies, Ltd. (Israel)
Date Prepared: December 2003
Classification: Class II
Predicate Devices:
- B-Twin Bone Expander System (K032358), by Disc-O-Tech Medical Technologies Ltd.
- KyphX Inflatable Bone Tamp (K981251, K010246, K032212), by Kyphon Inc.
Intended Use: As a conventional bone tamp for the reduction of fractures and/or creation of a void in cancellous bone in the spine, hand, tibia, radius and calcaneus.
System Description: Consists of an Expandable Tube, Delivery System, and Instrumentation Set.
Substantial Equivalence Argument: Based on having the same intended use, operating principles, design principles, similar/same materials, same packaging, and same/equivalent sterilization method as the B-Twin BE System predicate.
FDA Determination: FDA found the device substantially equivalent (K034037) to legally marketed predicate devices, allowing it to proceed to market under general controls.

Summary

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510(K) Summary

JAN 2 8 2004

Disc-O-Tech Medical Technologies Ltd. SKy Bone Expander System

Company Name

Disc-O-Tech Medical Technologies, Ltd.

3 Hasadnaot St., Herzliya

Israel, 46728

Submitter's Name and Contact Person

1. Yael Rubin
  Disc-O-Tech Medical Technologies, Ltd.

3 Hasadnaot St. Herzliya, Israel, 46728

Tel: 972-9-9511511, Fax: 972-9-9548939

1. Jonathan S. Kahan, Esq. 555 Thirteenth Street, NW, Washington, DC 20004 Tel: 202-637-5794, Fax: 202-637-5910

Date Prepared

December 2003

Trade/Proprietary Name

SKy Bone Expander System (SKy System)

Classification

Class II

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Predicate Devices

✓ B-Twin Bone Expander System (K032358), by Disc-O-Tech Medical Technologies Ltd.
✔ KyphX Inflatable Bone Tamp (K981251, K010246, K032212), by Kyphon Inc.

Intended Use

The SKy System is intended for use as a conventional bone tamp for the reduction of fractures and/or creation of a void in cancellous bone in the spine, hand, tibia, radius and calcaneus.

System Description

The SKy System consists of the following components:

√ Expandable Tube a tube-like component, mounted on a delivery system. Inserted into the bone in reduced 5-mm diameter configuration and expanded within the bone.
Delivery System used for the insertion, expansion, and retrieval of the expandable tube.
V Instrumentation Set a set of accessories to assist in insertion and location of the device.

Substantial Equivalence

The modified SKy System has the following similarities to the B-Twin BE System that previously received 510(k) concurrence:

/ Has the same intended use
Has the same operating principles
Incorporate the same design principles
Incorporate either the same or similar materials V
Has the same packaging, using the same materials and processes. >
Has the same, or equivalent, sterilization method, maintaining the same SAL. >

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 8 2004

Disco-O-Tech Medical Technologies Ltd. C/o Mr. Jonathan S. Kahan, Esq. Hogan and Hartson L.L.P. 555 Thirteenth Street, NW Washington, D.C. 20004-1109

Re: K034037

K054037
Trade/Device Name: SKy Bone Expander System (SKy System) Traders/contee Nambers: 21 CFR 888.1100, 21 CFR 888.4540 Regulation Names: Arthroscope, Orthopedic manual surgical instrument Regulatory Class: II Product Codes: HRX, HXG Dated: December 29, 2003 Received: December 29, 2003

Dear Mr. Kahan:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(x) prematice newnstantially equivalent (for the indications referenced and nave determined the arroomate devices marketed in interstate for use stated in the enclosure) to legally manced provide IDevice Amendments, or to
commerce prior to May 28, 1976, the enactment and one of the Federal Food. Drug commerce prior to May 28, 1976, the characteries of the Federal Food. Drug, devices that have been reciassified in accordance what approval application (PMA).
and Cosmetic Act (Act) that do not require approval as a provisions of the Act. The and Cosmetic Act (Act) that do not require approvate of the general controls of the Act. The You may, merciore, market the devices, salyest to annual registration, listing of
general controls provisions of the Act include requirements for annual registrations and general controls provisions of the fiel hereas seems against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it class If your device is classified (Sec above) this existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation FDA may be subject to such additional bentrolio. Entrologian be found in the Ood of Peachar 2003 concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not the Act Please be advised that I DA 3 issuated of a value complies with other requirements of the Act
that I'DA has made a determination that your device complies with other much that ITDA has made a decommandia an administered by other Federal agencies. You must of any Pederal statutes and regulations administered of registration and listing (21 comply with an the Act s requirements, meldang, which in the requirements as scheellership the cluding CFK Part 807), rabeing (21 CFR Part 820); good man 11 applicable, the clectronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and 11 applicable (1950 form in the quality systems (Sections (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 (301) 594-4659. 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-iree number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. 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): ____________________________________________________________________________________________________________________________________________________

SKy Bone Expander System (SKy System) Device Name:

Indication for Use:

The SKy System is intended for use as a conventional bone tamp for the reduction of fractures and/or creation of a void in cancellous bone in the spine, hand, tibia, radius and calcaneus.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam C. Provost

Division Sign-Off) Division biggeneral, Restorative and Neurological Devices

510(k) Number K034037

Page 32 of 35

Regulation Number and Section

§ 888.1100 Arthroscope.

(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. 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 § 888.9.