(108 days)
Not Found
No
The summary describes a mechanical suture anchor and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as a "Suture Anchor" used for "attachment of soft tissue to bone" in various repairs and reconstructions, which are therapeutic interventions.
No
The device description and intended use indicate that the Parcus MiTi Suture Anchors are used for the mechanical attachment of soft tissue to bone, making it a surgical fixation device, not a diagnostic one.
No
The device description clearly states it is a threaded, tapered fastener made from Titanium alloy and includes sutures, a driver, and is available in different diameters. These are all physical hardware components.
No, 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, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the Parcus MiTi Suture Anchors are "threaded, tapered fasteners for use in attachment of soft tissue to bone." The intended uses are all surgical procedures involving the direct attachment of tissue to bone within the body.
- No Specimen Analysis: There is no mention of analyzing any biological specimens from the patient. The device is implanted directly into the body.
Therefore, based on the provided information, the Parcus MiTi Suture Anchor is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Parcus MiTi Suture Anchors are indicated for attachment of soft tissue to bone. This product is intended for the following indications:
- Shoulder Rotator Cuff Repair, Acromioclavicular Separation Repair, Bankart Lesion Repair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, SLAP Lesion Repair.
- Knee Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair. Extra Capsular Reconstruction, Iliotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair.
- Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction, Achilles Foot/Ankle Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair.
- Elbow Tennis Elbow Repair, Biceps Tendon Reattachment.
- Hand/Wrist Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, TFCC.
Product codes (comma separated list FDA assigned to the subject device)
HWC, MBI
Device Description
The Parcus MiTi Suture Anchor is a threaded, tapered fastener for use in attachment of soft tissue to bone. The device is made from a Titanium alloy, Ti-6Al-4V ELI (ASTM F136). The product family includes devices that come preloaded with either one or two sutures between #3-0 and #2 in size either with or without attached needles, and a driver, and is available in three different diameters, 2.0mm, 2.5mm and 3.5mm. The 2.0mm anchor is offered in the following suture configurations: two #3-0 and one or two #2-0 sutures. The 2.5mm anchor is offered in the following suture configurations: two #3-0, two #2-0 and one #2 sutures. The 3.5mm anchor is offered in the following suture configurations: two #3-0, two #1 and two #2 sutures. All configurations are offered in multiple color variations and with or without attached needles.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Knee, Foot/Ankle, Elbow, Hand/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 pull out strength and insertion torque was measured for the Parcus MiTi Suture Anchors. The published literature was reviewed and side by side comparisons were done with the Parcus Medical and Smith & Nephew predicate devices. The results of the insertion torque testing, pullout force, and the literature review demonstrated that there were no significant differences between the Parcus MiTi Suture Anchors and the predicate devices.
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/0 description: The image displays the logo for PARCUS Medical, LLC, accompanied by the phrase "SURGICAL INNOVATION VALUE DRIVEN" beneath the logo. Above the logo, the text "K111000 JUL 28 2011 P.1/2" is present. The logo is in bold, black font, and the text below is in a smaller, lighter font.
510(k) Summarv
| Submitter: | Parcus Medical, LLC
839 South Neenah Ave.
Sturgeon Bay, WI 54234 |
|----------------------|-----------------------------------------------------------------------------------------------|
| Company Contact: | Barton Bracy
Phone: (920) 746-2972
Fax: (920) 746-2974 |
| Date Prepared: | April 8, 2011 |
| Trade Name: | Parcus MiTi Suture Anchor |
| Common Name: | Suture Anchor |
| Classification Name: | Fastener, Fixation, Non-Degradable, Soft Tissue
21 CFR 888.3040 - Product Code HWC and MBI |
Predicate Devices:
- Parcus V-LoX Titanium Suture Anchors (K090075) .
- Smith & Nephew Twinfix Ti 2.8 Suture Anchor (K053344) .
- Smith & Nephew MINITAC Ti 2.0 Suture Anchor (K000797) .
Device Description:
The Parcus MiTi Suture Anchor is a threaded, tapered fastener for use in attachment of soft tissue to bone. The device is made from a Titanium alloy, Ti-6Al-4V ELI (ASTM F136). The product family includes devices that come preloaded with either one or two sutures between #3-0 and #2 in size either with or without attached needles, and a driver, and is available in three different diameters, 2.0mm, 2.5mm and 3.5mm. The 2.0mm anchor is offered in the following suture configurations: two #3-0 and one or two #2-0 sutures. The 2.5mm anchor is offered in the following suture configurations: two #3-0, two #2-0 and one #2 sutures. The 3.5mm anchor is offered in the following suture configurations: two #3-0, two #1 and two #2 sutures. All configurations are offered in multiple color variations and with or without attached needles.
Intended Use:
The Parcus MiTi Suture Anchors are indicated for attachment of soft tissue to bone. This product is intended for the following indications:
- Shoulder Rotator Cuff Repair, Acromioclavicular Separation Repair, Bankart Lesion Repair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, SLAP Lesion Repair.
1
k 111 000
| PARCUS | |
|---|---|
| SURGICAL INNOVATION | |
| VALUE DRIVEN | |
| Knee | Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, |
| Posterior Oblique Ligament Repair, Extra Capsular Reconstruction, | |
| Iliotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair. | |
| Foot/Ankle | Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction, Achilles |
| Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament | |
| Repair. | |
| Elbow | Tennis Elbow Repair, Biceps Tendon Reattachment. |
| Hand/Wrist | Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral |
| Ligament Reconstruction, TFCC. |
Substantial Equivalence Summary:
The Parcus MiTi Suture Anchor is substantially equivalent to the predicate devices listed above in which the basic features and intended uses are very similar. Any differences between the MiTi Suture Anchor and the predicate devices are considered minor and do not raise questions concerning safety and effectiveness.
Summary Performance Data:
The pull out strength and insertion torque was measured for the Parcus MiTi Suture Anchors. The published literature was reviewed and side by side comparisons were done with the Parcus Medical and Smith & Nephew predicate devices. The results of the insertion torque testing, pullout force, and the literature review demonstrated that there were no significant differences between the Parcus MiTi Suture Anchors and the predicate devices.
Fax 1.920.746.2974
PARCUSMEDICAL.COM
Call 1.877.746.2972
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services-USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread, with three horizontal lines running through the body of the eagle. The image is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Parcus Medical, LLC % Mr. Barton Bracy Vice President Marketing and Product Development 839 South Neenah Avenue Sturgeon Bay, Wisconsin 54235
JUL 28 2011
Re: K111000
Trade/Device Name: Parcus MiTi Suture Anchors Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, MBI Dated: July 19, 2011 Received: July 20, 2011
Dear Mr. Bracy:
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. Barton Bracy
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark M. Milliman
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: _Parcus MiTi Suture Anchors
Indications for Use:
The Parcus MiTi Suture Anchors are indicated for attachment of soft tissue to bone. This product is intended for the following indications:
- Shoulder Rotator Cuff Repair, Acromioclavicular Separation Repair, Bankart Lesion Repair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, SLAP Lesion Repair.
- Knee Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair. Extra Capsular Reconstruction, Iliotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair.
- Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction, Achilles Foot/Ankle Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair.
- Elbow Tennis Elbow Repair, Biceps Tendon Reattachment.
- Hand/Wrist Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, TFCC.
FCC.
Muh M. Mulkun
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number