(253 days)
No
The document describes a mechanical implant and surgical instruments, with no mention of AI, ML, image processing, or data-driven analysis.
Yes.
The device is a humeral nail used for fixation of bone fractures, which is a therapeutic intervention.
No
The device is described as an intramedullary nail system used for the fixation of humeral fractures, nonunions, malunions, and for prophylactic nailing. Its description focuses on its physical components and function as a fixation device, not on diagnosing medical conditions.
No
The device description clearly states it includes physical components like nails, screws, and instruments, made of materials like carbon fiber reinforced polymer and titanium alloy. This indicates it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for the internal fixation of bone fractures in the humerus. This is a surgical implant used in vivo (within the body).
- Device Description: The description details a physical implant (nail and screws) made of carbon fiber and titanium, designed to be inserted into the bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo to treat a physical condition.
N/A
Intended Use / Indications for Use
Indications for the Quantum IM Composite Humeral Nail include simple humeral fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathological fractures; reconstruction, following tumor resection and grafting. The Quantum IM Composite Humeral Nail is indicated for fixation of fractures that occur in and between the proximal and distal third of the humerus.
Product codes (comma separated list FDA assigned to the subject device)
HSB
Device Description
The Quantum IM Composite Nailing System includes nails, interlocking screws and a set of instruments.
The Quantum IM Composite Nail is a cylindrical solid rod, made of carbon fiber reinforced polymer. Its diameter ranges from 7 to 8.5 mm, with lengths in the range of 180 to 280 mm. The nail provides for holes at its proximal and distal sections, designed for the insertion of the 3.5 mm self-tapping, cortical, titanium-alloy-made, interlocking screws. The nail has a closed, pointed distal end, and its proximal end incorporates a thread enabling connection of insertion/extraction instrumentation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
humeral, humerus
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)
Performance characteristics, evaluated per ASTM F 1264, are also comparable to those of predicate devices, thus demonstrating that the device is safe and effective for its intended use.
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.
K933518, K002783, K013449, K032588, K983942
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.
K052533, K022615, K073649, K031401
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
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.
0
510(K) Summary
JAN 2 1 2010
N.M.B. Medical Applications, Ltd. Quantum IM Composite Nailing System
Applicant Name
N.M.B. Medical Applications, Ltd.
11 Ha'hoshlim St., Herzeliya 46724, Israel
Contact Person
-
- Yael Rubin
N.M.B. Medical Applications, Ltd.
- Yael Rubin
11 Ha'hoshlim St., Herzliya 46724, Israel
Tel: +972 9 9511511, Fax: +972 9 9548939
-
- Jonathan S. Kahan, Esq. Hogan & Hartson LLP 555 Thirteenth Street, NW, Washington, DC 20004, U.S.A. Tel: 202-637-5794, Fax: 202-637-5910
Date Prepared
October 2009
Trade/Proprietary Name
Quantum IM Composite Nailing System (Quantum Nailing System)
Common Name Intramedullary Nailing System
Classification Name
Rod, Fixation, Intramedullary and Accessories (21 CFR §888.3020; Product Code HSB)
Page 1. & 3
1
Predicate Devices
Intended Use/Design/Technology/Operation
- 트 UHN Humeral Nailing System (Synthes: K933518)
- 미 Fixion® Interlocking Intramedullary Nailing System (N.M.B. Medical Applications, Ltd .; K002783, K013449, K032588)
(091425
- 다 Intramedullary Nail System (Smith & Nephew, Inc .; K983942)
Material
- KIMBA™ Spinal Implant (SIGNUS Medizintechnik GmbH; K052533) 대
- Spine-Tech™ Cement Restrictor (Centerpulse, Spine-Tech Division; K022615) .
- 다 Stackable Cage System (DePuy Spine, Inc .; K073649)
- Fixion® DHS System (N.M.B. Medical Applications, Ltd.; K031401) ·
Intended Use/Indications for Use
Indications for the Quantum IM Composite Humeral Nail include simple humeral fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathological fractures; reconstruction, following tumor resection and grafting. The Quantum IM Composite Humeral Nail is indicated for fixation of fractures that occur in and between the proximal and distal third of the humerus.
System Description
The Quantum IM Composite Nailing System includes nails, interlocking screws and a set of instruments.
The Quantum IM Composite Nail is a cylindrical solid rod, made of carbon fiber reinforced polymer. Its diameter ranges from 7 to 8.5 mm, with lengths in the range of 180 to 280 mm. The nail provides for holes at its proximal and distal sections, designed for the insertion of the 3.5 mm self-tapping, cortical, titanium-alloy-made, interlocking screws. The nail has a closed, pointed distal end, and its proximal end incorporates a thread enabling connection of insertion/extraction instrumentation.
Page 2 of 3
2
Substantial Equivalence
The Quantum IM Composite Nailing System intended use, design, materials, technological characteristics, and principles of operation are substantially equivalent to those of the predicate devices, as applicable.
Performance characteristics, evaluated per ASTM F 1264, are also comparable to those of predicate devices, thus demonstrating that the device is safe and effective for its intended use.
Page . 3 of 3
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
N.M.B. Medical Applications, Ltd. % Mr. Jonathan S. Kahan, Esq. Hogan & Hartson LLP 555 Thirteenth Street, North West Washington, District of Columbia 20004
JAN 21 2010
Re: K091425
Trade/Device Name: Quantum IM Composite Nailing System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: November 30, 2009 Received: December 3, 2009
Dear Mr. Kahan:
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 todevices 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
4
Page 2 -- Mr. Jonathan S. Kahan
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Barbara Buchu
Mark N. Mel Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
1091425
Indications for Use
510(K) Number (if known): K091425
Device Name: Quantum IM Composite Nailing System (Quantum Nailing System)
Indication for Use:
Indications for the Quantum IM Composite Humeral Nail include simple humeral fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathological fractures; reconstruction, following tumor resection and grafting. The Quantum IM Composite Humeral Nail is indicated for fixation of fractures that occur in and between the proximal and distal third of the humerus.
Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 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)
Quetta for mxm
Sign Division of Surgical, Or nopedic. and Restorative Devices
510(k) Number K091425