(85 days)
Not Found
No
The summary describes a passive, permanent implantable mesh made of PET for reinforcing rotator cuff repairs. There is no mention of any computational or algorithmic components, let alone AI/ML.
Yes
The device is intended for the reinforcement of the rotator cuff following or during repair, which is a therapeutic intervention aimed at improving a health condition.
No
The device is described as a permanent implantable device intended for reinforcement of the rotator cuff during or following repair, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a permanent implantable device constructed from fabric, which is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "reinforcement of the rotator cuff following or during repair by suture or suture anchors, where weakness exists in the soft tissue." This describes a surgical implant used to physically support and reinforce tissue.
- Device Description: The description details a "permanent implantable device" made of PET fabric, designed to be surgically attached to the rotator cuff. This is a physical medical device, not a diagnostic test.
- Lack of Diagnostic Function: There is no mention of the device being used to test a sample (blood, urine, tissue, etc.) or to provide information about a patient's health status through analysis of biological materials.
- Performance Study: The performance study focuses on clinical outcomes (Constant-Murley score, subjective shoulder value) related to the physical repair and function of the shoulder after implantation, not on diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Pitch-Patch does not fit this definition.
N/A
Intended Use / Indications for Use
The Pitch-Patch is a single use device intended to be used for reinforcement of the rotator cuff following or during repair by suture or suture anchors, where weakness exists in the soft tissue.
The Pitch-Patch is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide mechanical strength for the repair.
Product codes (comma separated list FDA assigned to the subject device)
FTL
Device Description
The Pitch-Patch is a permanent implantable device for reinforcement of rotator cuff tears. It is constructed from a warp knitted fabric with integral eyelets. It is reinforced around its perimeter and around each eyelet to increase the security of suture attachment. The Pitch-Patch is available in two sizes, to cover different tear sizes without trimming (30 x 20 mm and 35 x 25 mm). It should not be cut to size. The device is supplied sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
rotator cuff
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)
Performance Testing - Bench: A series of tests has been conducted and successfully completed in accordance with the Guidance for the Preparation of a Premarket Notification for a Surgical Mesh; Guidance for Industry and/or for FDA reviewers/Staff and/or Compliance. The results demonstrate that the Pitch-Patch provides appropriate mechanical properties for its use in soft tissue repair. The performance data benefit/risk analysis concluded that the differences encountered do not affect the safety and efficacy of the new device in relation to the predicate.
Performance Testing - Clinical: The Pitch-Patch device was used in a prospective cohort study of 50 patients. Clinical outcome was evaluated using the Constant-Murley score and the subjective shoulder value. Mean clinical midterm and final follow-up was 22 months (9-35 months) and 52 months (25-74 months), respectively. The mean Constant-Murley score increased significantly from 36.5 (+/-16.4 standard deviation [SD]) preoperatively to a midterm value of 81.2 (+/-9.6 SD: P
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with an abstract design. To the right of the seal, there is the FDA logo in blue, followed by the words "U.S. FOOD & DRUG" in a larger font and "ADMINISTRATION" in a smaller font. The logo is simple and professional, and it is easily recognizable.
August 13, 2021
Xiros Ltd Steve Curran Compliance Director Springfield House Lane, Whitehouse Lane Leeds. West Yorkshire LS19 7UE United Kingdom
Re: K211563
Trade/Device Name: Pitch-Patch Tissue Reinforcement Device Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTL Dated: May 16, 2021 Received: May 20, 2021
Dear Mr. Curran:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Deborah Fellhauer Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211563
Device Name Pitch-Patch Tissue Reinforcement Device
Indications for Use (Describe)
The Pitch-Patch is a single use device intended to be used for reinforcement of the rotator cuff following or during repair by suture or suture anchors, where weakness exists in the soft tissue.
The Pitch-Patch is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide mechanical strength for the repair.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| 区 Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary Pitch-Patch Tissue Reinforcement Device
Submitter Information
| Submitter: | Xiros, Ltd |
|---|---|
| Address: | Springfield House |
| Whitehouse Lane | |
| Leeds | |
| West Yorkshire | |
| LS19 7UE | |
| UK | |
| Telephone: | +44(0)1132387200 |
| Fax: | +44(0)1132387201 |
| Contact: | Dr. Steve Curran |
| Date Prepared: | May 13, 2021 |
Device Information
| Trade Name: | Pitch-Patch Tissue Reinforcement Device |
|---|---|
| Common Name: | Surgical Mesh |
| Classification: | Class II |
| Regulation: | 21 CFR 878.3300 |
| Classification Name: | Surgical Mesh Polymeric |
| Classification Panel: | General Plastic Surgery |
| Product Code: | FTL |
Purpose of Submission
The purpose of this submission is to gain clearance for a new orthopedic surgical mesh for use during rotator cuff repair to reinforce the tissue during and following repair surgery.
Predicate Device Information
The Pitch-Patch Reinforcement device described in this submission is substantially equivalent to the following predicate devices:
Surgicraft Surgical Mesh System (K072370) BioMerix Surgical Mesh (K070961)
Device Description
The Pitch-Patch is a permanent implantable device for reinforcement of rotator cuff tears. It is constructed from a warp knitted fabric with integral eyelets. It is reinforced around its perimeter and around each eyelet to increase the security of suture attachment. The Pitch-Patch is available in two sizes, to cover different tear sizes without trimming (30 x 20 mm and 35 x 25 mm). It should not be cut to size. The device is supplied sterile.
4
The Pitch-Patch is made from Polyethylene Terephthalate (PET) also referred as polyester. This a nonabsorbable material that has a long history of use in the orthopedic market.
Intended Use/Indications for Use
The Pitch-Patch is a single use device intended to be used for reinforcement of the rotator cuff, following or during repair by suture or suture anchors, where weakness exists in the soft tissue.
The Pitch-Patch is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide mechanical strength for the repair.
Comparison of Principles of Operation & Technological Characteristics
The Pitch-Patch has the same principles of operations as the predicate devices. They are all permanent implants intended to support the rotator cuff during and after a surgical repair.
Performance Data
The following performance testing has been completed for the Pitch-Patch:
- Simple Stitch Pull-Out Testing ●
- Burst Testing
- Tensile Testing of the base material .
- Tear Testing
- Testing to determine the density and pore size ●
- Biocompatibility ●
Performance Testing - Bench
A series of tests, listed above, has been conducted and successfully completed in accordance with the Guidance for the Preparation of a Premarket Notification for a Surgical Mesh; Guidance for Industry and/or for FDA reviewers/ Staff and/or Compliance. The results demonstrate that the Pitch-Patch provides appropriate mechanical properties for its use in soft tissue repair.
The performance data benefit/risk analysis concluded that the differences encountered do not affect the safety and efficacy of the new device in relation to the predicate.
Performance Testing - Clinical
The Pitch-Patch device was used in a prospective cohort study of 50 patients. Clinical outcome was evaluated using the Constant-Murley score and the subjective shoulder value. Mean clinical midterm and final follow-up was 22 months (9-35 months) and 52 months (25-74 months), respectively.
The mean Constant-Murley score increased significantly from 36.5 (+/-16.4 standard deviation [SD]) preoperatively to a midterm value of 81.2 (+/-9.6 SD: P