(101 days)
Not Found
No
The summary describes a mechanical bone expander system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is used for the reduction of fractures and/or creation of a void in cancellous bone in specific anatomical sites, and can be used in combination with bone cements for vertebroplasty or kyphoplasty procedures, all of which are therapeutic interventions.
No
This device is described as "intended for use as a conventional bone tamp for the reduction of fractures and/or creation of a void in cancellous bone." This is a therapeutic or surgical function, not a diagnostic one. It doesn't analyze data or provide information about a patient's medical condition.
No
The device description clearly lists physical components (expandable tube, delivery system, instrumentation set) which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical procedure involving the manipulation of bone within the body (in vivo). IVDs are used to examine specimens taken from the body (in vitro) to provide information about a patient's health.
- Device Description: The device components are instruments used for a surgical procedure, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of reagents, assays, or laboratory procedures typically associated with IVDs.
The SKy Bone Expander System is a surgical device used for orthopedic procedures.
N/A
Intended Use / Indications for Use
The SKy Bone Expander 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. In the spine, it may be used in combination with polymethylmethacrylate (PMMA) bone cernents that are legally marketed for use in vertebroplasty or kyphoplasty procedures.
Product codes
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
JUN 1 7 2004 . .
K0406/2
510(K) Summary
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. 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 June 2004
Trade/Proprietary Name
SKy Bone Expander System (SKy System)
Classification
Class II
1
Predicate Devices
- B-Twin BE System (K032358) by Disc-O-Tech Medical Technologies, Ltd. >
- SKy Bone Expander System (K034037) by Disc-O-Tech Medical Technologies, Ltd.
Intended Use
The SKy Bone Expander 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. In the spine, it may be used in combination with polymethylmethacrylate (PMMA) bone cernents that are legally marketed for use in vertebroplasty or kyphoplasty procedures.
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.
-
Instrumentation Set - a set of accessories to assist in insertion and location of the device.
Substantial Equivalence
In general, the SKy System intended use, design, materials, technological characteristics and principles of operation are substantially equivalent to those of currently cleared B-Twin BE and SKy Systems (K032358, K034037).
the submit and the submit of the submit of the submit of the subject of
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three horizontal bars extending from its body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 7 2004
Ms. Yael Rubin Director of Regulatory Affairs Disc-O-Tech Medical Technologies, Ltd. 3 Hasadnaot Street Herzliya 46728 Israel
Re: K040612
Ro40012
Trade/Device Name: Sky Bone Expander System (Sky System) Trade/DOTICO Number: 21 CFR 888.1100, 21 CFR 888.4540 Regulation Name: Arthroscope; Orthopedic manual surgical instrument Regulatory Class: II Product Code: HRX, HXG Dated: March 4, 2004 Received: March 24, 2004
Dear Ms. Rubin:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection 910(t) premier is substantially equivalent (for the indications felerenced above and nave determined on and and and one inces marketed in interstate for use stated in the cherosure to regally many a program and the Medical Device Amendments, or to comments provision to May 20, 7978, in economice with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). and Costience Act (Act) that do not require subject to the general controls provisions of the Act. The r ou may, merclore, market the device, est include requirements for annual registration, listing of general controls provisions of ractice, 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 If your device is classified (600 we 10, 2017 and on regulations affecting your device can
may be subject to such additional controls. Existing major and contribution FD to may be subject to subli additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ood of I casse concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Picase be advised that 117A : 15suarce of a succession ...
that FDA has made a determination that your device complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must of ally it catal statutes and regations and limited to: registration and listing (21 comply with an the 7tet 37equirements)01); good manufacturing practice requirements as set CTN i at 807), idocinig (21 OFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin maneting your and equivalence of your device to a legally premarket notification. The PDA mianing of castom.
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 If you desire specific advice for your ac 11.000. 4659. Also, please note the regulation entitled, comact the Office of Complance in (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational 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,
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
KO40612 510(K) Number (if known): ____________________________________________________________________________________________________________________________________________________
SKy Bone Expander System (SKy System) Device Name:
Indication for Use:
The SKy Bone Expander System is intended for use as a conventional bone tamp for the The biry Done and/or creation of a void in cancellous bone in the spine, hand, tibia, radius and calcaneus. In the spine, it may be used in combination with polymethacrylate (PMMA) bone cements that are legally marketed for use in vertebroplasty or kyphoplasty procedures.
Over-The-Counter Use AND/OR Prescription Use _ (Part 21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
Division of General, Restorative. and Neurological Devices
510(k) Number K040612
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