(160 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and fixation strength of a suture anchor system, with no mention of AI or ML technologies.
Yes
The device is described as a "suture anchor system" intended for "soft tissue to bone fixation" for various parts of the body (shoulder, foot and ankle, elbow, knee, hand and wrist, hip). This indicates it is used to treat or manage injuries or conditions, which aligns with the definition of a therapeutic device.
No
The device is a surgical implant (suture anchor) used for soft tissue to bone fixation, not for diagnosing conditions.
No
The device description explicitly states it is an "all-suture anchor device" made of physical materials (polyester, UHMWPE suture) and provided preloaded on a "disposable inserter." It also mentions "accessory instruments, including a drill bit and drill guide with obturator." These are all physical hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Eleven Blade Solutions, Inc. Q-Fix™ Suture Anchor System is a surgical implant used to fix soft tissue to bone during orthopedic procedures. It is a physical device inserted into the body, not a tool for analyzing biological samples.
The provided information clearly describes a surgical device for musculoskeletal repair, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Eleven Blade Solutions, Inc. Q-Fix™ Suture Anchor System is intended for soft tissue to bone fixation for:
Shoulder
Bankart lesion repair, SLAP lesion repair, Acromio-clavicular repair, Capsular shift/capsulolabral reconstruction, Deltoid repair, Rotator cuff repair, Biceps tenodesis
Foot and Ankle
Medial/lateral repair and reconstruction, Mid and forefoot repair, Hallux valgus reconstruction, Metatarsal ligament/tendon repair or reconstruction, Achilles tendon repair
Elbow
Ulnar or radial collateral ligament reconstruction, Lateral epicondylitis repair, Biceps tendon reattachment
Knee
Extra-capsular repair: MCL, LCL, and posterior oblique ligament, Illiotibial band tenodesis, Patellar tendon repair, VMO advancement, Joint capsule closure
Hand and Wrist
Collateral ligament repair, Sacpholunate ligament reconstruction, Tendon transfers in phalanx, Volar plate reconstruction
Hip
Acetabular labral repair
Product codes
MBI
Device Description
The Q-Fix™ Suture Anchor is an all-suture anchor device designed for soft tissue to bone fixation by expanding against bone when deployed. Made of a polyester sleeve-type structure with one or more strands of UHMWPE suture threaded through it, the anchor is provided preloaded on a disposable inserter. The inserter is used to deploy the anchor into the bone, with the suture remaining slideable within the anchor to facilitate attachment of the soft tissue.
The one-time use anchor is provided sterile, preloaded on the inserter. Additional accessory instruments, including a drill bit and drill guide with obturator are single use devices provided sterile for use during the orthopedic procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Foot and Ankle, Elbow, Knee, Hand and Wrist, Hip
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)
Design verification activities were performed as a result of the risk analysis. The 510(k) notice contains summaries of bench studies, which were conducted to evaluate the performance characteristics of the Q-Fix™ Suture Anchor System. Anchor Pull-out Strength, Cyclic Displacement, and Device Insertion Testing were performed. The data presented demonstrate that the performance characteristics of the Q-Fix™ Suture Anchor System are equivalent to the predicate devices and thus provide equivalent fixation strength within their intended use.
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
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It 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.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo for "ELEVEN BLADE SOLUTIONS". The word "ELEVEN" is in large, bold, sans-serif font, with the "V" stylized to look like two blades. Below "ELEVEN" is the phrase "BLADE SOLUTIONS" in a smaller, bold, sans-serif font.
Page 1/2
K122336
Q-Fix™ Suture Anchor System
January 7, 2013
JAN 9 2013
510(k) Summary
な
| General Company Information | |||
|---|---|---|---|
| Name: | Eleven Blade Solutions, Inc. | ||
| Contact: | Michael Kolber | ||
| Regulatory Affairs | |||
| Address: | 147 Hillbrook Dr. | ||
| Los Gatos, CA 95032 | |||
| Telephone: | 408-505-6626 | ||
| Fax: | 408-402-8361 | ||
| Date Prepared: | January 7, 2013 | ||
| General Device Information | |||
| Product Name: | Q-Fix™ Suture Anchor System | ||
| Common Name: | Suture Anchor | ||
| Classification: | 21CFR888.3040; Smooth or threaded metallic | ||
| bone fixation fastener | |||
| Device Class: | Class II | ||
| Product Code: | MBI | ||
| Predicate Devices | |||
| Manufacturer | Device Name | 510(k) Number | |
| Biomet Sports Medicine | Juggerknot Soft Anchor | K110145 | |
| Teleflex Medical | ForceFiber | K063778 | |
| Description | |||
| The Q-Fix™ Suture Anchor is an all-suture anchor device designed for soft tissue to | |||
| bone fixation by expanding against bone when deployed. Made of a polyester sleeve- | |||
| type structure with one or more strands of UHMWPE suture threaded through it, the | |||
| anchor is provided preloaded on a disposable inserter. The inserter is used to deploy | |||
| the anchor into the bone, with the suture remaining slideable within the anchor to | |||
| facilitate attachment of the soft tissue. | |||
| The one-time use anchor is provided sterile, preloaded on the inserter. Additional | |||
| accessory instruments, including a drill bit and drill guide with obturator are single | |||
| use devices provided sterile for use during the orthopedic procedure. | |||
| Intended Use (Indications) | |||
| The Eleven Blade Solutions, Inc. Q-Fix™ Suture Anchor System is intended for soft | |||
| tissue to bone fixation for: | |||
| Shoulder | |||
| Bankart lesion repair, SLAP lesion repair, Acromio-clavicular repair, Capsular | |||
| shift/capsulolabral reconstruction, Deltoid repair, Rotator cuff repair, Biceps | |||
| tenodesis | |||
| Foot and Ankle | |||
| Medial/lateral repair and reconstruction, Mid and forefoot repair, Hallux valgus |
.
1
122336
Image /page/1/Picture/1 description: The image shows the logo for "ELEVEN BLADE SOLUTIONS". The word "ELEVEN" is in large, bold, sans-serif font, with a stylized image of two blades forming a "V" in the middle. Below "ELEVEN", in a smaller, bold, sans-serif font, is the text "BLADE SOLUTIONS".
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K122336 Q-Fix™ Suture Anchor System January 7, 2013
reconstruction, Metatarsal ligament/tendon repair or reconstruction, Achilles tendon repair
Elbow
Ulnar or radial collateral ligament reconstruction, Lateral epicondylitis repair, Biceps tendon reattachment
Knee
Extra-capsular repair: MCL, LCL, and posterior oblique ligament, Illiotibial band tenodesis, Patellar tendon repair, VMO advancement, Joint capsule closure
Hand and Wrist
Collateral ligament repair, Sacpholunate ligament reconstruction, Tendon transfers in phalanx, Volar plate reconstruction
Hip
Acetabular labral repair
Substantial Equivalence
This submission supports the position that the Eleven Blade Solutions, Inc. O-Fix™ Suture Anchor System is substantially equivalent to the Biomet Juggerknot (K110145) and the Teleflex ForceFiber (K063778). The O-Fix™ Suture Anchor System has the following similarities to the previously cleared predicate device: the same intended use, same operating principle, similar technologies, and similar manufacturing process. Design verification activities were performed as a result of the risk analysis. The 510(k) notice contains summaries of bench studies, which were conducted to evaluate the performance characteristics of the O-Fix™ Suture Anchor System. Anchor Pull-out Strength, Cyclic Displacement, and Device Insertion Testing were performed. The data presented demonstrate that the performance characteristics of the Q-Fix™ Suture Anchor System are equivalent to the predicate devices and thus provide equivalent fixation strength within their intended use.
Conclusions
Eleven Blade Solutions, Inc. believes that the information provided demonstrates that the proposed device is substantially equivalent to the predicate devices and does not raise any new issues of safety or efficacy. Based on the indications for use, technological characteristics, and comparison to predicated devices, the Q-Fix™ Suture Anchor System has been shown to be substantially equivalent to predicate devices as described under the Federal Food, Drug and Cosmetic Act.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the graphic.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Eleven Blade Solutions, Incorporated % Mr. Michael Kolber Regulatory Affairs 147 Hillbrook Drive Los Gatos, California 95032
Letter dated: January 9, 2013
Re: K122336
Trade/Device Name: Eleven Blade Solutions, Incorporated. Q-Fix™ Suture Anchor System Regulation Number: 21 CFR 888.3040
Regulation Name: Smooth or threaded metallic bone fixation fastener.
Regulatory Class: Class II
Product Code: MBI
Dated: November 23, 2012
Received: November 26, 2012
Dear Mr. Kolber:
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, 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
3
Page 2 – Mr. Michael Kolber
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 yours.
Mark N. Melkerson
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K122336
Device Name: Eleven Blade Solutions, Inc. Q-Fix™ Suture Anchor System
Indications for Use: The Eleven Blade Solutions, Inc., Q-Fix™ Suture Anchor System is intended to be used for soft tissue to bone fixation for:
Shoulder
Bankart lesion repair, SLAP lesion repair, Acromio-clavicular repair, Capsular shift/capsulolabral reconstruction. Deltoid repair, Rotator cuff tear repair, Biceps tenodesis
Foot and Ankle
Medial/lateral repair and reconstruction, Mid and forefoot repair, Hallux valgus reconstruction, Metatarsal ligament/tendon repair or reconstruction. Achilles tendon repair
Elbow
Ulnar or radial collateral ligament reconstruction, Lateral epicondylitis repair, Biceps tendon reattachment
Knee
Extra-capsular repair: MCL, LCL, and posterior oblique ligament, Illiotibial band tenodesis, Patellar tendon repair, VMO advancement, Joint capsule closure
Hand and Wrist
Collateral ligament repair, Sacpholunate ligament reconstruction, Tendon transfers in phalanx, Volar plate reconstruction
Hip
Acetabular labral repair
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
Anton E. Dmitriev, PhD 2013.01.09 14:50:59 -05'00' Division of Orthopedic Devices