(315 days)
No
The summary describes a mechanical external fixation device and its reprocessing, with no mention of AI or ML in its function or intended use.
Yes
The "Intended Use" clearly states its indication for "treatment of fractures, osteotomy, arthrodesis, correction of deformities," and other medical conditions, which are therapeutic actions.
No
The device, an external fixation system, is used for the treatment of fractures and reconstructive orthopedic surgery, which are therapeutic interventions rather than diagnostic procedures. It does not mention any function for detecting, identifying, or monitoring a disease or condition.
No
The device description explicitly lists physical components like frames, clamps, rods, pins, etc., and mentions materials like metal alloys, plastic, and composites, indicating it is a hardware 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 the device as being used for external skeletal fixation and treatment of various bone-related conditions. This is a therapeutic and surgical application, not a diagnostic one.
- Device Description: The description details the components of an external fixation system, which are physical devices used to stabilize bones. This aligns with a surgical/therapeutic device, not a device used to examine specimens from the body.
- Anatomical Site: The anatomical site is the skeletal system/bone, which is the target of the physical fixation, not a source of biological specimens for in vitro testing.
- Performance Studies: The performance studies mentioned are bench and laboratory testing to demonstrate the performance of the reprocessed physical device and validation of the reprocessing process. This is consistent with evaluating the structural integrity and functionality of a surgical implant/device.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
Reprocessed external fixation devices are indicated for use in patients requiring external skeletal fixation oand treatment of fractures, osteotomy, arthrodesis, correction of deformities, fracture revision, bone reconstruction procedures, limb lengthening, correction of bony or soft tissue deformities and segmental bony or soft tissue defects.
Product codes
KTT, KTW, JEC
Device Description
External fixation devices are specially designed frames, clamps, rods, rod-to-rod couplings, pins, posts, fasteners, wire fixations, fixation bolts, washers, nuts, hinges, sockets, connecting bars and screws used for the management of bone fractures and reconstructive, as well as corrective, orthopedic surgery. Materials used include metal alloys, plastic and composites. These materials are chosen to address a wide range of fractures and applications as well as to allow for the appropriate amount of rigidity and stability.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed External Fixation Devices.
Biocompatibility
Validation of reprocessing
Performance testing demonstrates that Reprocessed External Fixation Devices perform as originally intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
JUN 2 4 2002
K012648 10F2
510(k) Summary of Safety and Effectiveness
| Submitter: | Alliance Medical Corporation
10232 South 51st Street
Phoenix, Arizona 85044 |
|----------------------|-------------------------------------------------------------------------------------------------------------|
| Contact: | Don Selvey
Vice President, Regulatory Affairs and Quality Assurance
(480) 763-5300 |
| Date of preparation: | 8 August 2001 |
| Name of device: | Reprocessed External Fixation Devices |
| Common Name: | External Fixation Devices, Fixation Appliance, Single/Multiple
Component and Invasive Traction Component |
| Classification Name: | Single/Multiple Component Metallic Bone Fixation Appliances and
Accessories |
Reprocessed device(s):
| MANUFACTURER | MODEL NUMBER | DESCRIPTION |
|---|---|---|
| HOWMEDICA | 3362-1-304 | OMEGA PLUS SIDEPLATE |
| HOWMEDICA | 4920-1-100 | TUBE-TO-ROD CLAMP |
| HOWMEDICA | 4940-1-020 | PIN-TO-ROD CLAMP |
| HOWMEDICA | 4940-1-058 | PIN-TO-ROD CLAMP |
| HOWMEDICA | 5029-1-511 | 5 HOLE LIGHTWEIGHT ALLOY |
| HOWMEDICA | 5029-2-110 | 10 HOLE LIGHTWEIGHT |
| HOWMEDICA | 5029-2-111 | 10 HOLE LIGHTWEIGHT ALLOY |
| HOWMEDICA | 5029-8-200 | STEEL ROD |
| HOWMEDICA | 5029-8-250 | STEEL ROD |
| HOWMEDICA | 5029-8-300 | STEEL ROD |
| HOWMEDICA | 5029-8-825 | CARBON FIBER ROD |
| HOWMEDICA | 5029-8-835 | CARBON FIBER ROD |
| HOWMEDICA | 5029-8-840 | CARBON FIBER ROD |
| HOWMEDICA | 5029-8-845 | CARBON FIBER ROD |
| HOWMEDICA | 5029-8-850 | CARBON FIBER ROD |
| HOWMEDICA | 5049-3-032 | ARTICULATION COUPLING |
| HOWMEDICA | 5150-2-380 | CARBON FIBER ROD |
| HOWMEDICA | 5150-2-391 | CARBON TUBE |
| HOWMEDICA | 5150-3-065 | EXTERNAL FIXATION PIN CLAMP |
| HOWMEDICA | 5151-3-065 | EXTERNAL FIXATION PIN CLAMP |
:
1
K012648
20F2
| Predicate device(s): | K802722 | Extended Ball Joint with Rod Hoffmann External
Fixation System | | | |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|------------|----------|--------------------|
| | K930836 | Howmedica | Mono-Tube™ | External | Fixation
System |
| | K971755 | Hoffman II Compact External Fixation System | | | |
| Device description: | External fixation devices are specially designed frames, clamps, rods,
rod-to-rod couplings, pins, posts, fasteners, wire fixations, fixation
bolts, washers, nuts, hinges, sockets, connecting bars and screws used
for the management of bone fractures and reconstructive, as well as
corrective, orthopedic surgery. Materials used include metal alloys,
plastic and composites. These materials are chosen to address a wide
range of fractures and applications as well as to allow for the
appropriate amount of rigidity and stability. | | | | |
| Intended use: | External Fixation Devices are intended to be used for the fixation of
supracondylar, or condylar fractures of the femur; for fusion of a joint;
for surgical procedures that involve cutting the bone, for fixation of
bone fractures; bone reconstruction; as a guide pin for insertion of other
implants; or may be implanted through the skin so that a pulling force or
traction may be applied to the skeletal system; and others may be used
for fixation of bone fractures, for bone reconstructions, as a guide pin
for insertion of other implants, or it may be implanted through the skin
so that a pulling force (traction) may be applied to the skeletal system. | | | | |
| Indications statement: | Reprocessed external fixation devices are indicated for use in patients
requiring external skeletal fixation oand treatment of fractures,
osteotomy, arthrodesis, correction of deformities, fracture revision,
bone reconstruction procedures, limb lengthening, correction of bony
or soft tissue deformities and segmental bony or soft tissue defects. | | | | |
| Technological characteristics: | The design, materials, and intended use of the Reprocessed External
Fixation Device s are identical to the predicate devices. The
mechanism of action of the Reprocessed External Fixation Device is
identical to the predicate devices in that the same standard
mechanical design, materials, shapes and sizes are utilized. There are
no changes to the claims, intended use, clinical applications, patient
population, performance specifications, or method of operation. | | | | |
| Performance data: | Bench and laboratory testing was conducted to demonstrate
performance (safety and effectiveness) of the Reprocessed External
Fixation Devices. | | | | |
| | Biocompatibility | | | | |
| | Validation of reprocessing | | | | |
| | Performance testing demonstrates that Reprocessed External Fixation
Devices perform as originally intended. | | | | |
| Conclusion: | In accordance with the Federal Food, Drug and Cosmetic Act 21
CFR Part 807 and based on the information provided in this
premarket notification, Alliance Medical Corporation concludes that
the modified device (the Reprocessed External Fixation Device) is
safe, effective and substantially equivalent to the predicate devices as
described herein. | | | | |
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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized symbol featuring three human profiles facing right, with flowing lines above and below them.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 4 2002
Mr. Don Selvey Vice President Regulatory Affairs and Quality Assurance Alliance Medical Corporation 10232 South 51st Street Phoenix, Arizona 85044
Re: K012623, K012634, K012645, K012648) Trade Name: Reprocessed External Fixation Devices Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT, KTW, JEC Dated: April 3, 2002 Received: April 4, 2002
Dear Mr. Selvey:
We have reviewed your Section 510(k) premarket notifications of intent to market the devices referenced above and have determined the devices are 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (PMA), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your devices 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 devices comply 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. Don Selvey
This letter will allow you to begin marketing your devices as described in your Section 510(k) premarket notifications. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices . SEM to proceed to the market.
If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Marke McMullens
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
Enclósure
4
Indications for Use Statement
K012648 510(k) Number (if known):
Device Name: Alliance Medical Corporation Reprocessed External Fixation Devices
Indications for Use: Reprocessed external fixation devices are indicated for use in patients requiring external skeletal fixation oand treatment of fractures, osteotomy, arthrodesis, correction of deformities, fracture revision, bone reconstruction procedures, limb lengthening, correction of bony or soft tissue deformities and segmental bony or soft tissue defects.
Mark N Milkerson
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number_
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (per 21 CFR 801.109)
or
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
CONFIDENTIAL
Alliance Medical Corporation Reprocessed External Fixation Devices Traditional 510(k)