(76 days)
Not Found
No
The summary describes a physical medical device (a surgical sling) and its mechanical properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is used for the "treatment of stress urinary incontinence."
No
The device is a pubourethral sling used for the treatment of stress urinary incontinence, not for diagnosing a condition.
No
The device description clearly states it is a "Pre-shaped Duel-component mesh Polypropylene and bioabsorbable polymer," indicating it is a physical implant, not software.
Based on the provided information, the Herniamesh T-sling is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of stress urinary incontinence (SUI) by providing support to the urethra. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: It's a surgical implant made of mesh materials.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information about a physiological state, health, or disease. It doesn't analyze blood, urine, tissue samples, etc.
IVD devices are used to perform tests on samples taken from the body to diagnose, monitor, or screen for conditions. The Herniamesh T-sling is a surgical device used to physically support anatomical structures.
N/A
Intended Use / Indications for Use
The Herniamesh T-sling is a dual-component pubourethral sling for the treatment of stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
Product codes
PAH
Device Description
Pre-shaped Duel-component mesh Polypropylene and bioabsorbable polymer
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Pubourethral
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)
Mechanical testing, scanning electron microscopy, biocompatibility and in vivo safety and effectiveness testing. The physical and mechanical characteristics of the Hermiamesh T-Sling meet or exceed those of the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Burst Strength: 28.4 (10² Kpa)
Suture Retention (N): warp 43, weft 55, 45° 52
Pore Size: 797.4μ & 228.3μ, Porosity 62.4%
Tensile Strength: warp 31.1, weft 33.1, 45° 29.7
Tissue Ingrowth: Complete tissue incorporation of implant
Predicate Device(s)
Reference Device(s)
Not Found
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
Premarket Notification for Herniamesh T-Sling
Summary of Safety and Effectiveness
The Hermiamesh T-Sling is substantially equivalent to the TVT (Tension-free Vaginal The neimanteer. I warketed by Ethicon Inc. and the BioSling™ - Bioabsorbable Polymer Sling & Surgical Mesh ourrently marketed by Prosury Inc. / Injectx Inc. The 510 (K) "Substantial Equivalence" Decision-Making Process (detailed)" decision tree was utilized to make a determination of substantial equivalence (see Exhibit 1). The answers to the following questions lead to a determination of substantial. equivalence.
- Does the new device have the same indication statement?
Yes, the Hermiamesh T-Sling has the same intended use as the legally marketed predicate devices listed above. All are pubourethral slings for the treatment of stress uninary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphinder deficiency. Therefore, the Herniamesh T-Sling has the same intended use as the predicate devices and is considered to be "substantially equivalent."
- Does the new device have same technological characteristics, e.g. design, materials, indication etc?
No, the Hermiamesh T-Sling has different technological characteristics. However, the technological differences meet or exceed the functional requirements of surgical meshes compared to the predicate devices. Please refer to Table of Similarities and Differences / Substantial Equivalence to Predicate Devices.
- Could the new technological characteristics affect safety and effectiveness?
Yes, the new technological characteristics could affect safety and effectiveness. The differences in safety and effectiveness meet or exceed the reguirements of surpical mesthes compared to predicate devices.
- Do the new characteristics raise new types of safety or effectiveness questions?
No, the safety and effectiveness questions are not new and include issues such as materials, pore size, tensile strength, siture retertion, and biocompatibility. Sufficient data has been provided in this premarket notification to address any new safety and efficacy questions, Additionally, there are a variety of other meshes ourrently on the market with different. characteristics compared to the Hermiamesh T-Sling or the predicate devices.
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1
Summary of Safety and Effectiveness (continued)
- Do accepted scientific methods exist for assessing the effects of the new characteristics?
Yes. The effects of the new characteristics of the Herniamesh T-Sling can be assessed by r ess. The encour a the now a mestes. These include mechanical testing, scanning electron microscopy, biocompatibility and in vivo safety and effectiveness testing.
- Are performance data available to assess the effects of the new characteristics?
Yes. These tests include mechanical testing, scanning electron microscopy, biocompatibility testing and in vivo testing.
- Do performance data demonstrate equivalence?
Yes. The physical and mechanical characteristics of the Hermiamesh T-Sling meet or exceed those of the predicate devices. Please refer to Table of Similarities and Differences / Substantial Equivalence to Predicate Devices.
Based on this information the Hemiamesh T-Sling is determined to be substantially equivalent to the predicate devices.
ర
2
Table of Similarities and Differences / Substantial Equivalence to Predicate Devices (Continued)
| Feature | Herniamesh T-Sling | Ethicon TVT | Injectx Inc BioSling™ |
|---|---|---|---|
| Burst | |||
| Strength | 28.4 (10² Kpa) | 55 ± 3 (10² Kpa) | Substantially |
| Equivalent | |||
| Suture | |||
| Retention (N) | warp 43 | ||
| weft 55 | |||
| 45° 52 | warp 52 ± 9 | ||
| weft 51 ± 7 | |||
| 45° 57 ± 3 | Substantially | ||
| Equivalent | |||
| Pore Size | 797.4μ & 228.3μ | ||
| Porosity 62.4% | Substantially Equivalent | ||
| Porosity 87% | Substantially | ||
| Equivalent | |||
| Tensile | |||
| Strength | warp 31.1 | ||
| weft 33.1 | |||
| 45° 29.7 | warp 23 ± 6 | ||
| weft 15 ± 5 | |||
| 45° 14 ± 5 | Substantially | ||
| Equivalent | |||
| Tissue Ingrowth | Complete tissue incorporation | ||
| of implant | Complete tissue | ||
| incorporation of implant | Not Tested |
Note: Values for Prolene TVT were taken from the textbook: Prostheses and Abdominal Wall Hemias by Dr. Robert Bendavid (pages 197,200)
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3
| Feature | Herniamesh T-Sling | Ethicon TVT | Injectx Inc BioSling™ |
|---|---|---|---|
| 510(k) No. | To be determined | K974098 | K010533 |
| Classification | Class II: Polymeric Surgical | ||
| Mesh | Class II: Polymeric | ||
| Surgical Mesh | Class II: Polymeric | ||
| Surgical Mesh | |||
| Indication | Pubourethral sling for | ||
| treatment of stress urinary | |||
| incontinence (SUI) resulting | |||
| from urethral hypermobility | |||
| and/or intrinsic sphincter | |||
| deficiency | Pubourethral sling for | ||
| treatment of stress urinary | |||
| incontinence (SUI) | |||
| resulting from urethral | |||
| hypermobility and/or | |||
| intrinsic sphincter | |||
| deficiency | Pubourethral sling for | ||
| treatment of stress urinary | |||
| incontinence (SUI) | |||
| resulting from urethral | |||
| hypermobility and/or | |||
| intrinsic sphincter | |||
| deficiency | |||
| Product Design | Pre-shaped | ||
| Duel-component mesh | |||
| Polypropylene and | |||
| bioabsorbable polymer | Pre-shaped | ||
| Polypropylene | |||
| mesh | Pre-shaped | ||
| bioabsorbable polymer | |||
| and Surgical mesh | |||
| Materials | Polypropylene & | ||
| Polydioxanone | |||
| (Bioabsorbable Polymer) | Polypropylene | Bioabsorbable polyester | |
| Polymer | |||
| Sterilization | Eto | Eto | Eto |
| Packaging | Tyvek pouch with outer heat | ||
| sealed foil pouch | PVC tray with Tyvek back | Substantially Equivalent | |
| Size | 2cm x 15cm | 1.1cm x 45cm | Substantially Equivalent |
Table of Similarities and Differences / Substantial Equivalence to Predicate Devices
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Herniamesh USA, Inc. % Ms. Lorena Trabucco 8 Orange Drive JERICHO NY 11753
SEP 2 8 2012
Re: K020652 Trade/Device Name: T-Sling Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: PAH Dated: February 21, 2002 Received: February 28, 2002
Dear Ms. Trabucco:
This letter corrects our substantially equivalent letter of May 15, 2002.
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 (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.
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
5
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 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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" (21 CFR 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,
Sincerely yours,
Benjamin R. Perkins
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Premarket Notification for Herniamesh T-Sling
Attachment # 1
Indications for Use Form
510(k) Number: K020652
Device Name: T-Sling
Indications For Use:
The Herniamesh T-sling is a dual-component pubourethral sling for the treatment of stress r ice recimatinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_V (per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
K020652 510(k) Number .