(140 days)
Not Found
No
The summary describes a mechanical bone expander system and does not mention any AI or ML components or functionalities.
Yes
The device is intended for the "reduction of fractures and/or creation of a void in cancellous bone," which are direct therapeutic actions.
No
The device is described as an expander system intended for the reduction of fractures and/or creation of a void in cancellous bone, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly lists physical components like an expandable tube, delivery system, and instrumentation set, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- B-Twin BE System Function: The description clearly states the B-Twin BE System is a surgical tool used within the body to reduce fractures and create voids in bone. It is a mechanical device for surgical intervention, not for analyzing biological samples.
The intended use and device description focus on a surgical procedure and the physical manipulation of bone, which is the opposite of an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The B-Twin BE System is intended for use as 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 B-Twin BE 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
Prescription Use
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.
K981251, K010246, K010988, K012967, K023437
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
032356
DEC 1 7 2003
Disc-O-Tech Medical Technologies, Ltd. B-Twin BE System 510(k)
510(K) Summary
Disc-O-Tech Medical Technologies Ltd.
B-Twin 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
- Jonathan S. Kahan, Esq. 555 Thirteenth Street, NW, Washington, DC
Tel: 202-637-5794, Fax: 202-637-5910
Date Prepared
July 2003
Trade/Proprietary Name
B-Twin Bone Expander System (B-Twin BE System)
Classification
Class II
1
Predicate Devices
- V KyphX Inflatable Bone Tamp (K981251, K010246), by Kyphon Inc.
- V Fixion Interlocking Proximal Femoral Intramedullary Nailing System (K010988, K012967, K023437) by Disc-O-Tech Medical Technologies, Ltd.
Intended Use
The B-Twin BE System is intended for use as 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 B-Twin BE 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 B-Twin BE System intended use, design, material, technological characteristics and principles of operation are substantially equivalent to those of Kyphon's KyphX Inflatable Bone Tamp (K981251, K010246). In addition, with respect to certain issues like sterilization, equivalence is claimed to the different Fixion Intramedullary Nailing Systems (e.g., the Fixion PF - K010988, K012967, K023437). Expandable Tube material equivalence is claimed to polymeric tubes for medical applications.
Page 50 of 53
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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle with three stripes extending from its wing.
DEC 1 7 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Disc-O-Tech Medical Technologies Ltd. c/o Mr. Jonathan S. Kahan, Esq. Hogan & Hartson L.L.P. 555 Thirteenth Street, NW Washington, D.C. 20004-1109
Re: K032358
Trade/Device Name: B-Twin Bone Expander System (B-Twin BE 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: October 3, 2003 Received: October 3, 2003
Dear Mr. Kahan:
We have reviewed your Section 510(k) premarket notification of intent to market the device w o nave review four be 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 10 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 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 complics 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.
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-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
INDICATIONS FOR USE
510(k) Number (if known): K032358
Device Name:
B-Twin Bone Expander System (B-Twin BE System)
Indications For Use:
The B-Twin Bone Expander System (B-Twin BE 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 _____________________________________________________________________________________________________________________________________________________________ V (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
Civision Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K032358
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