(217 days)
No
The device description and performance studies focus on the mechanical properties of sutures and crimps, with no mention of AI or ML.
Yes.
The device is used for "soft tissue to bone and bone to bone approximation and fixation during orthopedic procedures," which addresses a medical condition or health problem.
No
Explanation: The device is described as multifilament stainless steel sutures with crimps intended for approximation and fixation during orthopedic procedures. Its function is to hold tissues and bones together, which is a therapeutic or reconstructive action, not a diagnostic one.
No
The device description clearly details physical components such as sutures, crimps, needles, washers, a suture guide, and a K-wire, indicating it is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states the device is a "Multifilament stainless steel suture with crimps" intended for "soft tissue to bone and bone to bone approximation and fixation during orthopedic procedures." This is a surgical implant used directly within the body for mechanical support and repair.
- Lack of Specimen Analysis: There is no mention of the device being used to analyze any biological specimens.
- Anatomical Site: The indicated anatomical sites (elbow, foot, ankle, knee, shoulder, and wrist) are where the device is surgically implanted, not where specimens are collected for analysis.
Therefore, this device falls under the category of a surgical implant or medical device used for mechanical fixation, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Multifilament stainless steel sutures with crimps are intended for use in soft tissue to bone and bone to bone approximation and fixation during orthopedic procedures in the elbow, foot, ankle, knee, shoulder, and wrist for indications such as: Elbow - biceps tendon attachment; Foot and Ankle - achilles tendon attachment; Knee - patella tendon attachment to bone; Shoulder -biceps tendon tenodesis; Wrist - scapho-lunate approximation.
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
Multifilament stainless steel sutures with crimps are intended for use in soft tissue to bone and bone to bone approximation and fixation during orthopedic procedures in the elbow, foot, ankle, knee, shoulder, and wrist for indications such as: Elbow - biceps tendon attachment; Foot and Ankle - achilles tendon attachment; Knee - patella tendon attachment to bone; Shoulder -biceps tendon tenodesis; Wrist - scapho-lunate approximation.
Multifilament Stainless Steel Sutures with Crimps are available in a range of USP sizes (4-0 to #3) and lengths, attached to stainless steel needles of various types and sizes.
Multifilament SS Sutures are manufactured in IX19, 7X7 or 7X19 filament constructions. The sutures are identified by black and white tips which are used as a guide at the tip, and are removed prior to the end of the procedure. The sutures and tips were cleared for use under the PONTIS 510(k), K101126.
The washer is available in the following sizes:
000-0739_1-01 Washer, Plate - 0.012", .045"
000-0739_1-00 Washer, Plate - 0.012", .062"
000-0764 Washer, Plate, 2-Hole - 0.012"
The suture guide and the cannulated K-wire are available in one size.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
elbow, foot, ankle, knee, shoulder, and wrist
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)
The verification and validation testing of the Multifilament Stainless Steel Suture with Crimps included knot failure force compared to crimp failure force, pull out strength, attachment strength, static testing and ultimate load following cyclic loading. Bench testing demonstrated that the mechanical properties are substantially equivalent for tendon to bone and bone to bone approximation.
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.
Mitek G11 Quick Anchor Plus - K041115, Arthrex Swivelock - K101823, Smith and Nephew Endobutton - K081098, PONTIS Orthopaedics ferroFIBRETM - K081060, Pioneer Surgical Technologies SilCoat Sternal Cable - K993286
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.
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.
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JUN 2 6 2014
ATTACHMENT 2
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Image /page/0/Picture/3 description: The image shows the word "PONTIS" in a stylized font. There is a curved line above the word, and the letters are outlined in black. To the right of the word is the trademark symbol.
ORTHOPAEDICS
510(k) Summary
| Owner's Name | Leonard Gordon |
|---|---|
| Submitter Address | 2299 Post Street Suite 107 |
| San Francisco, CA 94115 | |
| Phone Number | (415) 567-8935 |
| Fax Number | (415) 567-8934 |
| 510(k) Owner | PONTIS Orthopaedics, LLC |
| Contact Person | Leonard Gordon |
| Date Prepared | April 22, 2014 |
| Trade Name | Multifilament Stainless Steel Suture with Crimp |
| Common name | Stainless Steel Suture |
| Classification Name | Smooth or Threaded Metallic Bone Fixation Fastener |
| Section | § CFR 888.3040 |
| Product Code | Primary - MBI |
| Predicate Device(s) | Mitek G11 Quick Anchor Plus - K041115 |
| Arthrex Swivelock - K101823 | |
| Smith and Nephew Endobutton - K081098 | |
| PONTIS Orthopaedics ferroFIBRETM - K081060 | |
| Pioneer Surgical Technologies SilCoat Sternal Cable - K993286 | |
| Device Description | Multifilament stainless steel sutures with crimps are intended for use in |
| soft tissue to bone and bone to bone approximation and fixation during | |
| orthopedic procedures in the elbow, foot, ankle, knee, shoulder, and | |
| wrist for indications such as: Elbow - biceps tendon attachment; Foot | |
| and Ankle - achilles tendon attachment; Knee - patella tendon | |
| attachment to bone; Shoulder -biceps tendon tenodesis; Wrist - | |
| scapho-lunate approximation. |
Multifilament Stainless Steel Sutures with Crimps are available in a
range of USP sizes (4-0 to #3) and lengths, attached to stainless steel
needles of various types and sizes.
Multifilament SS Sutures are manufactured in IX19, 7X7 or 7X19
filament constructions. The sutures are identified by black and white
tips which are used as a guide at the tip, and are removed prior to the
end of the procedure. The sutures and tips were cleared for use under
the PONTIS 510(k), K101126. |
| The washer is available in the following sizes: | |
| 000-0739_1-01 Washer, Plate - 0.012", .045" | |
| 000-0739_1-00 Washer, Plate - 0.012", .062" | |
| 000-0764 Washer, Plate, 2-Hole - 0.012" | |
| The suture guide and the cannulated K-wire are available in one size. | |
| Reason for 510(k)
Indications for Use | New Device
Multifilament stainless steel sutures with crimps are intended for use in
soft tissue to bone and bone to bone approximation and fixation during
orthopedic procedures in the elbow, foot, ankle, knee, shoulder, and
wrist for indications such as: Elbow - biceps tendon attachment; Foot
and Ankle - achilles tendon attachment; Knee - patella tendon
attachment to bone; Shoulder -biceps tendon tenodesis; Wrist -
scapho-lunate approximation. |
| Technological
Characteristics | The Multifilament stainless steel suture is the same suture as was
cleared under K081060. Each suture size and number of suture strands
will require a different crimp size. |
| | All biocompatibility testing performed, which was conducted under the
predicate submission K081060 remain applicable for this submission-
as the materials are the same. This indicates that the components are
safe for their intended use. |
| | The PONTIS Multifilament Stainless Steel Suture with Crimps is a
single use, sterile implantable device, sterilized by ethylene oxide. The
predicate devices are single use, sterile implantable device, sterilized
by gamma irradiation and ethylene oxide. |
| Substantial
Equivalence | The Multifilament Stainless Steel Suture with Crimps is substantially
equivalent in design, manufacturing materials, intended use, principles
of operation, and technical characteristics to the predicates. The risk
analysis performed, raised no new issues of safety or effectiveness. |
| Nonclinical Tests
Performed | The verification and validation testing of the Multifilament Stainless
Steel Suture with Crimps included knot failure force compared to
crimp failure force, pull out strength, attachment strength, static testing
and ultimate load following cyclic loading. Bench testing
demonstrated that the mechanical properties are substantially
equivalent for tendon to bone and bone to bone approximation. |
| Conclusions Drawn | Bases on the indications for use, technological characteristics and
performance test results, the Multifilament Stainless Steel Suture with
Crimps is substantially equivalent to the predicate. |
PONTiS Orthopaedics
:
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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in bold, uppercase letters. The text is horizontally oriented and appears to be a header or title. The words are evenly spaced and the font is consistent throughout the text.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 26, 2014
PONTiS Orthopaedics LLC Leonard Gordon, M.D. President 2229 Post Street, Suite 103 San Francisco, California 94115
Re: K133579
Trade/Device Name: Multifilament Stainless Steel Sutures with Crimps Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: May 19, 2014 Received: May 20, 2014
Dear Dr. Gordon:
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
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/Resources[orYou/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 yours,
Lori A. Wiggins
- for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
ATTACHMENT 1
Statement of Indications for Use
510(k) Number: K133579
Manufacturer: PONTiS Orthopaedics, LLC
Device Name: Multifilament Stainless Steel Sutures with Crimps
Indications for Use:
Multifilament stainless steel sutures with crimps are intended for use in soft tissue to bone and bone to bone approximation and fixation during orthopedic procedures in the elbow, foot, ankle, knee, shoulder, and wrist for indications such as: Elbow - biceps tendon attachment; Foot and Ankle - achilles tendon attachment; Knee - patella tendon attachment to bone; Shoulder -biceps tendon tenodesis; Wrist - scapho-lunate approximation.
Prescription Use XX (21 CFR Part 801 Subpart D)
AND/OR
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Exemption (ODE)
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices
Page 1/1
PONTiS Orthopaedics
6/23/14