(30 days)
Not Found
No
The document describes a mechanical bone tamp system and does not mention any AI or ML components or functionalities.
No.
The device description indicates its use for mechanical purposes like reducing fractures and creating voids, not for treating a disease or condition in a therapeutic manner.
No
Explanation: The device description states its intended use is for the reduction of fractures and/or creation of a void in cancellous bone, which are therapeutic/interventional actions, not diagnostic ones.
No
The device description explicitly lists physical hardware components: Expandable Tube, Delivery System, and Instrumentation Set.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for surgical intervention (reduction of fractures, creation of a void in bone) within the body. IVDs are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a patient's health status.
- Device Description: The components described (expandable tube, delivery system, instrumentation set) are all tools used for a surgical procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other elements typically associated with in vitro diagnostics.
This device is a surgical instrument used for orthopedic procedures.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
HRX, HXG
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.
- Instrumentation Set a set of accessories to assist in insertion and location of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
spine, hand, tibia, radius and calcaneus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K032358, K981251, K010246, K032212
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
-
- Yael Rubin
Disc-O-Tech Medical Technologies, Ltd.
- Yael Rubin
3 Hasadnaot St. Herzliya, Israel, 46728
Tel: 972-9-9511511, Fax: 972-9-9548939
-
- 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
1
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. >
2
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.
3
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
4
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
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