(82 days)
No
The device description and performance studies focus on the mechanical properties and biocompatibility of a physical implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as a "Tissue Reinforcement Device" intended to reinforce soft tissues, which falls under the definition of a therapeutic device as it directly treats or supports a medical condition (tendon repair).
No
The device is described as a "Tissue Reinforcement Device" intended for surgical reinforcement of soft tissues during tendon repair. Its function is to provide mechanical support rather than to diagnose or detect medical conditions.
No
The device description clearly states it is a permanent implantable device constructed from a warp knitted fabric made of Polyethylene Terephthalate (PET), which is a physical material, not software.
Based on the provided information, the Pitch-Patch Tissue Reinforcement 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.
- Pitch-Patch Function: The Pitch-Patch is a permanent implantable device used during surgery to reinforce soft tissues that have been repaired. It is a physical device that is placed within the body to provide structural support.
- Lack of Diagnostic Activity: The device does not analyze biological samples or provide diagnostic information. Its function is purely mechanical reinforcement.
The description clearly indicates it's a surgical implant for tissue reinforcement, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Pitch-Patch Tissue Reinforcement Device is a single use device intended for reinforcement of soft tissues that are repaired by suture or other fixation devices during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps tendon or other tendons.
The Pitch-Patch Tissue Reinforcement Device is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, quadriceps tendon or other tendons. Sutures, used to repair the tear, and sutures or other fixation devices, 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, OWX
Device Description
The Pitch-Patch is a permanent implantable device for reinforcement of soft tissues that are repaired by suture or other fixation devices during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps tendon. 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, by Gamma Irradiation to an SAL of 10-6.
The Pitch-Patch is made from Polyethylene Terephthalate (PET) also referred as polyester. This a non-absorbable material that has a long history of use in the orthopedic market.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues, tendon, rotator cuff, patellar, Achilles, biceps, quadriceps tendon
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 following performance testing has been completed for the Pitch-Patch Tissue Reinforcement Device:
- Suture Retention Testing
- Ultimate Strength Testing
- Cyclic Testing
- Packaging Testing
- Biocompatibility Testing
- LAL Bacterial Endotoxin Testing (
§ 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
May 31, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Xiros Ltd % John Mahoney General Manager Xiros Inc 20 Cabot Blvd., Suite 300 Mansfield, Massachusetts 02448
Re: K230671
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, OWX Dated: March 10, 2023 Received: March 10, 2023
Dear John Mahoney:
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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 mediation-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,
Sara S. Thompson -S
For
Yu-Chieh Chiu, Ph.D. Acting Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K230671
Device Name Pitch-Patch Tissue Reinforcement Device
Indications for Use (Describe)
The Pitch-Patch Tissue Reinforcement Device is a single use device intended for reinforcement of soft tissues that are repaired by suture or other fixation devices during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps tendon or other tendons.
The Pitch -Patch Tissue Reinforcement Device is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps tendon or other tendons. Sutures, used to repair the tear, and sutures or other fixation devices, used to attach the tissue to the bone, provide mechanical strength for the repair.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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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 26, 2023 |
Device Information
| Trade Name: | Pitch-Patch Tissue Reinforcement Device |
|---|---|
| Common Name: | Surgical Mesh |
| Classification: | Class II |
| Regulation: | 21 CFR 878.3300 |
| Classification Name: | Mesh, surgical polymeric |
| Mesh, surgical, non-absorbable, orthopedics, reinforcement | |
| of tendon | |
| Classification Panel: | Orthopedic |
| Product Code: | FTL/OWX |
Predicate/Reference Device Information
The Pitch-Patch Tissue Reinforcement Device described in this submission is substantially equivalent to the following:
Predicate/Reference Device Information
| Primary predicate: | Poly-Tape Soft Tissue Reinforcement Device |
|---|---|
| Premarket Notification: | K220091 |
| Product Code: | FTL,OWX |
| Secondary predicate: | FlexBand Plus (FlexBand/FlexPatch) |
| Premarket Notification: | K192112 |
| Product Code: | FTL |
| Reference device: | Pitch-Patch Tissue Reinforcement Device |
| Premarket Notification: | K211563 |
| Product Code: | FTL, OWX |
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Device Description
The Pitch-Patch is a permanent implantable device for reinforcement of soft tissues that are repaired by suture or other fixation devices during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps tendon. 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, by Gamma Irradiation to an SAL of 10-6.
The Pitch-Patch is made from Polyethylene Terephthalate (PET) also referred as polyester. This a non-absorbable material that has a long history of use in the orthopedic market.
Intended Use/Indications for Use
The Pitch-Patch Tissue Reinforcement Device is a single use device intended for reinforcement of soft tissues that are repaired by suture or other fixation devices during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps tendon or other tendons.
The Pitch-Patch Tissue Reinforcement Device is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, quadriceps tendon or other tendons. Sutures, used to repair the tear, and sutures or other fixation devices, used to attach the tissue to the bone, provide mechanical strength for the repair.
Comparison of Principles of Operation & Technological Characteristics
The Pitch-Patch device has the same principles of operations as the predicate devices. They are all implants intended for the reinforcement of soft tissues that are repaired by suture or other fixation devices. The devices are used in various surgical procedures where soft tissue reinforcement is needed.
At a high level, the subject and predicate devices are based on the following same technological elements:
- . Polyester Surgical Mesh
- Implant shares the load placed on the primary repair and provides ● a structural scaffold for torn or damaged soft tissue
- . Provides consistent reinforcement during healing period
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The following technological differences exist between the subject and predicate devices:
- The Poly-Tape Soft Tissue Reinforcement Device predicate varies in size from . the subject device, but is made from the same material and has the same intended use.
- The FlexBand Plus (FlexBand/FlexPatch) predicate device is made from . different material than the subject device, but has the same intended use and is available in similar sizes.
Performance Data
The following performance testing has been completed for the Pitch-Patch Tissue Reinforcement Device:
- Suture Retention Testing ●
- Ultimate Strength Testing ●
- . Cyclic Testing
- Packaging Testing
- . Biocompatibility Testing
- LAL Bacterial Endotoxin Testing (