(30 days)
Not Found
No
The summary describes a mechanical bone expander system with no mention of software, algorithms, or any terms related to AI/ML.
No
Explanation: The device is intended for the reduction of fractures and/or creation of a void in cancellous bone, which are direct interventions in the body for treatment purposes. Therefore, it is a therapeutic device.
No
The device is described as a bone tamp for fracture reduction and void creation in cancellous bone, which is a therapeutic rather than diagnostic function.
No
The device description clearly lists physical components like an "Expandable Tube," "Delivery System," and "Instrumentation Set," indicating it is a hardware-based medical device.
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 surgical procedure involving the reduction of fractures and creation of voids in bone. This is a direct intervention on the patient's body.
- Device Description: The components listed (expandable tube, delivery system, instrumentation set) are all physical tools used for a surgical procedure.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (blood, urine, tissue, etc.) to provide information about a physiological state, health, or disease.
IVD devices are used in vitro (outside the body) to examine specimens from the body. This device is used in vivo (inside the body) for a therapeutic purpose.
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.
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 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)
K032358, K034037, K981251, K010246, K032212
Reference Device(s)
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
MAY 1 2 2004 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 46728 Israel
Submitter's Name and Contact Person
Yael Rubin Disc-O-Tech Medical Technologics, Ltd. 3 Hasadnaot St., Herzliya 46728, Israel Tel: 972-9-9511511, Fax: 972-9-9548939
Date Prepared
April 2004
Trade/Proprietary Name
SKy Bone Expander System (SKy System)
Classification
Class II
1
Predicatc Devices
-
V B-Twin Bone Expander System (K032358), by Disc-O-Tech Medical Technologics Ltd.
: -
V SKy Bone Expander System (K034037), 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 diameter configuration and expanded within the bone.
- V 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 SKy System that previously received 510(k) concurrence:
- ✓
- Has the same operating principles >
- Incorporate the same design principles >
- Incorporate the same materials >
- Has the same packaging, using the same materials and processes.
- Has the same sterilization method, maintaining the same SAL. >
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services (HHS) in the USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 2 2004
Ms. Yael Rubin Director of Regulatory Affairs Disc-O-Tech Medical Technologies Ltd. 3 Hasadnaot Street Herzliya 46728 Isracl
Re: K040939
Trade/Device Name: SKy Bone Expander System (SKy System) Regulation Number: 21 CFR 888.1100; 21 CFR 888.4540 Regulation Name: Arthroscope, Orthopedic manual surgical instrument Regulatory Class: II Product Code: HRX, HXG Dated: April 8, 2004 Received: April 12, 2004
Dear Ms. Rubin:
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 cither 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 (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.
3
Page 2 - Ms. Yael Rubin
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-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Muriam 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 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.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
(Part 21 CFR 801 Subpart C)
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Musican C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number Ko40939 ---