(113 days)
No
The 510(k) summary describes a bioabsorbable surgical mesh made from P4HB. There is no mention of AI, ML, image processing, or any software-driven analysis or decision-making capabilities. The focus is on the material properties and physical performance of the mesh.
Yes
The device is a surgical mesh intended to reinforce soft tissue and repair fascial defects, which are therapeutic interventions.
No
The device is a surgical mesh intended to reinforce or repair soft tissue. Its purpose is therapeutic or reparative, not diagnostic.
No
The device description clearly states it is a sterile, single-use surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB), which is a physical material. It is not software.
Based on the provided information, the GalaFLEX LITE Scaffold is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states it's for reinforcing soft tissue and repairing fascial defects in patients undergoing surgery. This is a direct surgical intervention on the body, not a test performed on samples taken from the body.
- Device Description: It's described as a "surgical mesh" and a "surgical scaffold," which are terms associated with implantable or surgically placed devices.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The GalaFLEX LITE Scaffold is a therapeutic device used during surgery.
N/A
Intended Use / Indications for Use
GalaFLEX LITE Scaffold is intended to reinforce soft tissue, where weakness exists, in patients undergoing plastic and reconstructive surgery, or for use in procedures involving soft tissue repair, such as the repair of fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
Product codes
OOD
Device Description
GalaFLEX LITE Scaffold is a sterile, single-use device for prescription use only. It is a bioabsorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB). P4HB is a biologically derived polymer which is extruded into monofilament fibers and knitted into a surgical scaffold. The P4HB material is the predicate device, TephaFLEX Light Mesh (K113721) and the reference device, Phasix Mesh (K142818) in terms of formulation and the manufacturing processes. P4HB is absorbed by the body through a process of hydrolysis and hydrolytic enzymatic digestion typically within 18 to 24 months. The material components and manufacturing processes used to produce the subject device is substantially equivalent to the subject device will only be offered as a nondyed (clear) surgical scaffold. The subject device has the predicate device: soft tissue repair/reinforcement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, fascial defects
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)
FDA Guidance "Guidance for the Preparation of a Premarket Notification for a Surgical Mesh" issued March 02, 1999 was used to determine appropriate bench and in vivo testing for the subject device includes the physical and functional characteristics as recommended in the Surgical Mesh quidance. In vivo rabbit study for the subject device includes the performance specifications and absorption time.
The subject device met all of the performance requirements as described. All samples utilized in the performance testing were representative of the subject device in terms of device design, manufacturing, packaqing and sterilization. The testing results demonstrate that GalaFLEX LITE Scaffold is substantially equivalent to the predicate device, TephaFLEX Light Mesh (K113721).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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 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.
April 09, 2024
Tepha, Inc Rajagopalan Prithi Regulatory Affairs Specialist 99 Hayden Avenue Suite 360 Lexington, Massachusetts 02421
Re: K233999
Trade/Device Name: GalaFLEX LITE Scaffold Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: OOD Dated: December 18, 2023 Received: December 18, 2023
Dear Rajagopalan Prithi:
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 (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 available 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
1
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product: and 21 CFR 820.100. Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
2
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,
Tek N. Digitally signed by Tek N. Lamichhane -S Lamichhane -Date: 2024.04.09 S 08:35:21 -04'00' Tek N. Lamichhane, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
GalaFLEX LITE Scaffold
Indications for Use (Describe)
GalaFLEX LITE Scaffold is intended to reinforce soft tissue, where weakness exists, in patients undergoing plastic and reconstructive surgery, or for use in procedures involving soft tissue repair, such as the repair of fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
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)
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510(k) Summary
Prepared on: 2023-12-18
Contact Details
| Applicant Name | Tepha, Inc. | |
|---|---|---|
| Applicant Address | 99 Hayden Avenue Suite 360 Lexington MA 02421 United States | |
| Applicant Contact Telephone | 4259001327 | |
| Applicant Contact | Mrs. Prithi Rajagopalan | |
| Applicant Contact Email | Prithi.Rajagopalan@bd.com | |
| Device Name | 21 CFR 807.92(a)(2) | |
| Device Trade Name | GalaFLEX LITE Scaffold | |
| Common Name | Surgical mesh | |
| Classification Name | Surgical Film | |
| Regulation Number | 878.3300 | |
| Product Code | OOD | |
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K113721 | TephaFLEX Light Mesh | OOD |
| Device Descrintion Summary | ||
| 1 CED 207 00/2/1\ |
GalaFLEX LITE Scaffold is a sterile, single-use device for prescription use only. It is a bioabsorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB). P4HB is a biologically derived polymer which is extruded into monofilament fibers and knitted into a surgical scaffold. The P4HB material is the predicate device, TephaFLEX Light Mesh (K113721) and the reference device, Phasix Mesh (K142818) in terms of formulation and the manufacturing processes. P4HB is absorbed by the body through a process of hydrolysis and hydrolytic enzymatic digestion typically within 18 to 24 months. The material components and manufacturing processes used to produce the subject device is substantially equivalent to the subject device will only be offered as a nondyed (clear) surgical scaffold. The subject device has the predicate device: soft tissue repair/reinforcement.
Phasix Mesh (K142818) is used as a reference device specification values of the subject device are being harmonized with the BD P4HB product line, particularly Phasix Mesh (K142818), following the acquisition of Tepha, Inc. by BD in July 2021.
Intended Use/Indications for Use
GalaFLEX LITE Scaffold is intended to reinforce soft tissue, where weakness exists, in patients undergoing plastic and reconstructive surgery, or for use in procedures involving soft tissue repair of fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
Indications for Use Comparison
The subject device and the cited predicate/reference devices have identical intended uses of soft tissue repair/reinforcement. The subject device, and the predicate have similar in use. The subject device and the reference device have similar indications of
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(5)
5
use wherein the reference device is intended for use specifically in hernia repairs and the subject device is used in general soft tissue repair/reinforcement and this does not constitute a new intended use.
Technological Comparison
The intended use, materials, technological characteristics (i.e., design, material, chemical composition), packaging materials/ components, sterilization (ethylene oxide with SAL 10^-6), principal of operation, and manufacturing process for the subject device and the predicate device, TephaFLEX Light Mesh (K113721) are substantially equivalent. Since the and predicate device are similar, no new safety and effectiveness concerns are raised.
21 CFR 807.92(a)(6)
Refer to the 'Technological Comparison Table' attached below for a comparison of the technological characteristics for the subject device, GalaFLEX LITE Scaffold, and the predicate device, TephaFLEX Light Mesh (K113721).
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
FDA Guidance "Guidance for the Preparation of a Premarket Notification for a Surgical Mesh" issued March 02, 1999 was used to determine appropriate bench and in vivo testing for the subject device includes the physical and functional characteristics as recommended in the Surgical Mesh quidance. In vivo rabbit study for the subject device includes the performance specifications and absorption time.
Clinical Tests Summary: Not Applicable.
The subject device met all of the performance requirements as described. All samples utilized in the performance testing were representative of the subject device in terms of device design, manufacturing, packaqing and sterilization. The testing results demonstrate that GalaFLEX LITE Scaffold is substantially equivalent to the predicate device, TephaFLEX Light Mesh (K113721).
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| Device
Characteristics | GalaFLEX LITE Scaffold
(Subject Device) | TephaFLEX Light Mesh (K113721)
(Predicate Device) |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Classification | Identical to predicate device. | Class II
Surgical Mesh 21 CFR 878.3300
Product Code: OOD |
| Material | Identical to predicate device. | Poly-4-hydroxybutyrate (P4HB) |
| Device Sizes | Identical to predicate device. | Offered in single sheets of varying shapes
and sizes ranging from 1x2 inches to 10x14
inches and may be cut to the shape or sizes
desired for a specific application. |
| Intended Use | Identical to predicate device. | Soft tissue repair/reinforcement |
| Indications for
Use | GalaFLEX LITE™ Scaffold is intended to
reinforce soft tissue where weakness exists
in patients undergoing plastic and
reconstructive surgery, or for use in
procedures involving soft tissue repair, such
as the repair of fascial defects that require
the addition of a reinforcing or bridging
material to obtain the desired surgical result. | TephaFLEX Light Mesh is intended to
reinforce soft tissue where weakness exists
in patients undergoing plastic and
reconstructive surgery, or for use in
procedures involving soft tissue repair, such
as the repair of hernia or other fascial
defects that require the addition of a
reinforcing or bridging material to obtain
the desired surgical result. |
| Patient
Contact
Classification | Identical to predicate device. | Permanent implant device with tissue/bone
contact (>30 days) |
| Packaging
materials and
configurations | Identical to predicate device. | The device is held within a medical grade
Tyvek envelope which is placed in a foil
pouch. The pouch is placed into an SBS
carton. |
| Sterilization | Identical to predicate device. | Ethylene Oxide SAL