(216 days)
Not Found
No
The device description and performance studies focus on mechanical fixation and do not mention any computational or analytical capabilities that would suggest AI/ML. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are also explicitly marked as "Not Found".
Yes
The device is used for ACL reconstruction, which is a medical procedure to repair an injured knee ligament and restore function. This falls under the definition of a therapeutic device.
No
The device is described as an "Adjustable Juxtacortical Fixation Device" used for ACL reconstruction, which indicates it is a surgical implant designed for repair, rather than for diagnosing a condition.
No
The device description clearly states it consists of a physical implant (adjustable nonabsorbable braided loop and titanium button) and is supplied sterile, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as juxtacortical fixation for ACL reconstruction." This describes a surgical implant used to physically stabilize a ligament during surgery.
- Device Description: The description details a physical implant made of a braided loop and titanium button, designed for surgical implantation.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) or to provide information about a patient's health status or disease. IVDs are used for diagnosis, monitoring, or screening.
The PULLUP® device is a surgical implant used in a reconstructive procedure, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The PULLUP® device is designed to be used as juxtacortical fixation for ACL reconstruction.
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The PULLUP® Adjustable Juxtacortical Fixation Device consists of an adjustable nonabsorbable braided loop and titanium button. The system is preloaded with traction threads.
The PULLUP® Adjustable Juxtacortical Fixation Device is available in 2 versions:
- -PULLUP® for cortical tunnels having a diameter of 4.5 mm
- PULLUP®XL for cortical tunnels having a diameter between 5 and 10 mm -
The implant is supplied sterile, ready to use.
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)
Non clinical performance testing demonstrated that PULLUP® device is as safe, as effective, and performs at least as safely and effectively as its predicate devices. No clinical data has been presented.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human face in profile, with three overlapping faces suggesting community and connection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
November 17, 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
SBM Sciences for Bio Materials Mr. Denis Clement CEO Zi Du Monge 65100 Lourdes France
Re: K151004
Trade/Device Name: PULLUP® Adjustable Juxtacortical Fixation Device Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: October 15, 2015 Received: October 15, 2015
Dear Mr. Clement:
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
1
Page 2 - Mr. Denis Clement
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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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 vours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Traditional 510(k) PULLUP® Adjustable Juxtacortical Fixation System
Image /page/2/Picture/2 description: The image shows the logo for Science & Bio Materials (SBM). The logo consists of the letters S, B, and M in gray, with the words "Science & Bio Materials" written in a smaller font size below the letters. To the right of the letters are four gray triangles pointing to the right. The second triangle from the left has a blue gradient pattern.
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K151004
Device Name
PULLUP® Adjustable Juxtacortical Fixation Device
Indications for Use (Describe)
The PULLUP® device is designed to be used as juxtacortical fixation for ACL reconstruction.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
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FORM FDA 3881 (8/14)
Page 1 of 1
PSC Publiching Sarvascer 3011 x 443-67201 FF
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SECTION 5
510(k) SUMMARY
1. GENERAL INFORMATION
| Type of 510(k) | TRADITIONAL |
|---|---|
| Trade Name | PULLUP® Adjustable Juxtacortical Fixation Device |
| CFR section | 21CFR 888.3040 |
| Classification Name | Fastener, fixation, nondegradable, soft tissue |
| Device panel | ORTHOPEDIC |
| Product Code | MBI |
| Class | II |
| Legally marketed predicate devices | K112990 TightRope RT manufactured by Arthrex, Inc. |
| K130033 ToggleLoc System manufactured by Biomet | |
| Manufacturing Corp. | |
| Submitter | SCIENCE FOR BIOMATERIALS |
| Sciences et Bio Matériaux | |
| ZI du Monge | |
| F 65100 LOURDES - FRANCE | |
| Registration Number : 3004549189 | |
| Contact | Denis CLEMENT, CEO |
| Tel : +33 (0)5 62 42 21 01 | |
| Fax : +33 (0)5 62 42 21 00 | |
| e-mail : denis.clement@sbm-fr.com | |
| Regulatory contact : Anne COSPIN-LATAPIE | |
| e-mail : anne.cospin@sbm-fr.com |
4
Traditional 510(k) PULLUP® Adjustable Juxtacortical Fixation System
Image /page/4/Picture/2 description: The image shows the logo for Science & Bio Materials (SBM). The logo consists of the letters S, B, and M, with the B in a different color than the S and M. Underneath the letters is the text "Science & Bio Materials". To the right of the letters are three triangles, the middle one with a gradient pattern.
2. DEVICE DESCRIPTION
The PULLUP® Adjustable Juxtacortical Fixation Device consists of an adjustable nonabsorbable braided loop and titanium button. The system is preloaded with traction threads.
The PULLUP® Adjustable Juxtacortical Fixation Device is available in 2 versions:
- -PULLUP® for cortical tunnels having a diameter of 4.5 mm
- PULLUP®XL for cortical tunnels having a diameter between 5 and 10 mm -
The implant is supplied sterile, ready to use.
3. INDICATIONS FOR USE
The PULLUP® device is designed to be used as juxtacortical fixation for ACL reconstruction.
4. PERFORMANCE DATA
Non clinical performance testing demonstrated that PULLUP® device is as safe, as effective, and performs at least as safely and effectively as its predicate devices. No clinical data has been presented.
5. SUBSTANTIAL EQUIVALENCE
The PULLUP® device is substantially equivalent to its predicate devices Arthrex TightRope RT (K112990) and Biomet ToggleLoc (K130033). Verification and validation tests demonstrate that the PULLUP® device is as safe, as effective, and performs as safely and effectively as its predicate device.
Summary preparation date: October 20, 2015