(103 days)
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.
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.
The Quantum Medical Concepts, LLC Framewalker 2.0 is an external fixation system, a "Single Use" walking aid designed to be affixed to the foot ring portion of an external ring fixator. It is intended for patients undergoing procedures requiring ring fixation of the lower extremity. The device provides a stable platform below the foot to protect the foot and allow limited ambulation.
The provided documentation, K111993, indicates that no non-clinical or clinical testing was provided to establish acceptance criteria or device performance. The submission relied on demonstrating substantial equivalence to legally marketed predicate devices (E-Z Frame External Support Boot, K043289, and Ace Fischer External Fixation System, K083789) based on identical intended use and geometrically similar foot platform components.
Therefore, the requested information regarding acceptance criteria and performance studies is not available in the provided text. All sections below would be marked as "Not Applicable" or "Not Provided" in the context of this specific 510(k) submission.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Provided | Not Provided |
Explanation: The 510(k) submission explicitly states "Non-Clinical Testing: None Provided." and "Clinical Testing: None provided." The approval was based on substantial equivalence to predicate devices, not on specific performance data or established acceptance criteria for the Framewalker itself.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not Applicable (No test set data provided)
- Data Provenance: Not Applicable (No test set data provided)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: Not Applicable (No test set data provided)
- Qualifications of Experts: Not Applicable (No test set data provided)
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not Applicable (No test set data provided)
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
- MRMC Study: No, Not Applicable (This device is a physical walking aid, not an AI-assisted diagnostic tool for human readers.)
- Effect Size: Not Applicable
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: No, Not Applicable (This device is a physical walking aid, not an algorithm.)
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not Applicable (No ground truth data or performance studies were conducted for this device.)
8. The sample size for the training set
- Sample Size: Not Applicable (No training set data provided, as no algorithm or performance study was conducted.)
9. How the ground truth for the training set was established
- Ground Truth Establishment: Not Applicable (No training set or ground truth was established for this device.)
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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, LLC3518 SE 21st Ave.Portland, Oregon 97202 |
| Contact Person: | Alicia Bach, Office ManagerQuantum Medical Concepts, LLCPH 503-233-3984FX 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 fixationappliances 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.
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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.
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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
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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
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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 |
|---|---|---|
| --------------- | --------- | ------------- |
Ra 9
§ 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.