(103 days)
Not Found
No
The device description and intended use clearly describe a mechanical walking aid for external ring fixators, with no mention of AI/ML capabilities or related concepts like image processing, training/test sets, or performance metrics typically associated with AI/ML devices.
No
The device is a walking aid designed to be used with an external ring fixator, providing a stable platform for ambulation, rather than directly treating a medical condition itself.
No
The device, Framewalker, is described as a "walking aid" designed to provide a stable platform for patients with external ring fixators on the foot and ankle, allowing for limited ambulation and protection. Its intended use focuses on physical support and mobility, not on diagnosing medical conditions or processing medical data to aid in diagnosis.
No
The device description clearly states "Framewalker is a 'Single Use' walking aid designed to the foot ring portion of an external ring fixator," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description and Intended Use: The description of the Framewalker clearly states it is a "walking aid designed to the foot ring portion of an external ring fixator." Its purpose is to provide a stable platform for limited ambulation and protection of the foot during treatment with an external fixator.
- Lack of Specimen Analysis: There is no mention of the device being used to collect, prepare, or analyze any biological specimens from the patient.
- Focus on Mechanical Support: The device's function is entirely mechanical, providing support and protection to the foot and aiding in ambulation.
Therefore, the Framewalker falls under the category of a medical device used for physical support and rehabilitation, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
This device is indicated for use in patients who are undergoing external ring fixation of the Foot and Ankle for the following conditions:
For use in the treatment of fracture fixation (open and closed), pseudarthrosis or nonunions of long bones, limb lengthening by distraction, correction of bony or soft tissue deformities and correction of segmental bony or soft tissue defects.
Product codes
KTT
Device Description
Framewalker is a "Single Use" walking aid designed to the foot ring portion of an external ring fixator. The Framewalker is intended for patients who are undergoing procedures requiring ring fixation of the lower extremity. The device is applied to the foot ring portion of a ring fixation frame in order to provide a stable platform below the foot to both protect the bottom of the foot and to allow a patient limited ambulation during treatment as determined by a physician.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Foot and Ankle; long bones (in relation to fracture fixation, pseudarthrosis or nonunions)
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)
Non-Clinical Testing: None Provided.
Clinical Testing: None provided.
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
Quantum Medical Concepts, LLC Traditional 510(k) Submission June 20, 2011
. - ****
K111993 (pg 1/2)
510(k) Summary
OCT 2 4 2011
| Date: | June 20, 2011 |
|---|---|
| Applicant/Sponsor: | Quantum Medical Concepts, LLC |
| 3518 SE 21st Ave. | |
| Portland, Oregon 97202 | |
| Contact Person: | Alicia Bach, Office Manager |
| Quantum Medical Concepts, LLC | |
| PH 503-233-3984 | |
| FX 503-233-8541 | |
| Proprietary Name: | Framewalker 2.0 |
| Common Name: | External Fixation System |
| Classification Name: | Class II, 21CFR 888.3030- Single/Multiple component metallic bone fixation |
| appliances and accessories | |
| Product Code: | KTT- Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component |
Legally Marketed Devices to Which Substantial Equivalence Is Claimed: The FrameWalker has an identical use and is substantially equivalent to the sole portion of the E-Z Frame External Support Boot, K043289 and the Ace Fischer External Fixation System, K083789. Ref. surgical technique supplied in appendix "B" pg. 15 P/N 880-04-015 'Elevator Attachment'.
Device Description: Framewalker is a "Single Use" walking aid designed to the foot ring portion of an external ring fixator. The Framewalker is intended for patients who are undergoing procedures requiring ring fixation of the lower extremity. The device is applied to the foot ring portion of a ring fixation frame in order to provide a stable platform below the foot to both protect the bottom of the foot and to allow a patient limited ambulation during treatment as determined by a physician.
1
K111993 (pg 2/2)
Quantum Medical Concepts, LLC Traditional 510(k) Submission June 20, 2011
Intended Use: This device is indicated for use in patients who are undergoing external ring fixation of the Foot and Ankle for the following conditions:
For use in the treatment of fracture fixation (open and closed), pseudarthrosis or nonunions of long r of ass in and a strention, correction of bony or soft tissue deformities and correction of segmental bony or soft tissue defects.
Summary of Technologies: The intended use is identical to the predicate devices shown and the foot platform components are geometrically similar to the EZ-Frame listed in the predicates. The Framewalker incorporates connection methods which are common in size, type and materials to compatible existing ring fixation systems.
Non-Clinical Testing: None Provided.
Clinical Testing: None provided.
2
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 stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 2 4 2011
Quantum Medical Concepts, LLC % Alicia Bach 3518 SE 21st Ave. Portland. OR 97202
Re: K111993
Trade/Device Name: Framewalker Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT Dated: October 13, 2011 Received: October 19, 2011
Dear Ms. Bach:
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. Iisting 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
3
Page - 2 - Ms. Alicia Bach
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.
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/ReportaProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
incerely yours,
Mark N. Melkerson Auch Co. 1. A Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Quantum Medical Concepts, LLC Traditional 510(k) Submission Júne 20, 2011
Indications for Use
510(k) Number (if known): K111993(pg 1/1)
Device Name: Framewalker
Indications For Use:
This device is indicated for use in patients who are undergoing external ring fixation of the Foot and Ankle for the following conditions:
For use in the treatment of fracture fixation (open and closed), pseudarthrosis or nonunions of long bones, limb lengthening hy distraction, correction of bony or soft tissue deformities and correction of segmental bony or soft tissue defects.
| Prescription Use | X | AND/OR Over-The-Counter Use | |
|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (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)
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
| 510(k) Number | K111993 | Page 1 of 1 |
|---|---|---|
| --------------- | --------- | ------------- |
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