(253 days)
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.
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.
This 510(k) summary describes a medical device, the Quantum IM Composite Nailing System, and its substantial equivalence to predicate devices, rather than a study proving performance against acceptance criteria for a new AI/software-as-a-medical-device (SaMD) product.
Therefore, most of the requested information regarding acceptance criteria, AI performance metrics, expert adjudication, and training/test set details are not applicable to this document. This submission focuses on demonstrating that a physical medical device (an intramedullary nailing system) is safe and effective through comparison to existing, legally marketed devices.
However, I can extract the relevant information from the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria. Instead, it asserts substantial equivalence to predicate devices. The performance characteristic evaluated is mechanical.
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices in intended use, design, materials, technological characteristics, and principles of operation. | "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 comparable to predicate devices. | "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." |
2. Sample size used for the test set and the data provenance
Not applicable. This is a physical medical device. The "test set" would refer to mechanical testing, not a dataset for an algorithm. The document mentions evaluation "per ASTM F 1264," which is a standard for mechanical testing of intramedullary fixation devices. The specific sample size or provenance of the materials tested under this standard is not detailed in this 510(k) summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a physical medical device. "Ground truth" in this context would refer to material properties or mechanical test results, not expert consensus on medical images or clinical outcomes.
4. Adjudication method for the test set
Not applicable. Mechanical testing typically follows standardized protocols (e.g., ASTM F 1264), and results are based on measurement, not adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. This is a physical medical device, not an AI/SaMD.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is a physical medical device, not an AI/SaMD.
7. The type of ground truth used
For mechanical performance, the "ground truth" would be the measured physical and mechanical properties and performance under standardized testing conditions (ASTM F 1264) compared to known properties of predicate devices.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/SaMD.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device, not an AI/SaMD.
{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
§ 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.