(262 days)
The IvyAIR Meniscus System is intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures. The lvyAIR Meniscus System is indicated for use in meniscal repairs and allograft transplant procedures. The lvyAlR Meniscus System device is intended to be used for anchoring the allograft to the meniscal rim during allograft transplant procedures.
The IvyAIR Meniscus System is an all-inside meniscus repair device. Each device includes two non-absorbable polymer implants, pre-tied with 2-0 non-absorbable suture and pre-loaded into a needle delivery system. The IvyAIR System is available in three needle configurations: Curved. Straight and Reverse Curve to allow the surgeon a choice for access to the desired zone of the meniscus. The IvyAIR Meniscus System is provided sterile for single use only.
This document describes the IvyAIR Meniscus System, a medical device for meniscal repair. The submission focuses on demonstrating substantial equivalence to a predicate device rather than providing a study proving performance against specific acceptance criteria for a novel AI device. Therefore, a direct response to some of the requested points ("AI assistance effect size," "sample size for the training set," "how ground truth for the training set was established") is not applicable or not explicitly detailed in the provided text, as the device is a physical surgical suture retention system, not an AI-powered diagnostic or assistive tool.
However, I can extract information related to the performance data and "acceptance criteria" as they pertain to the device's engineering design and biocompatibility testing in comparison to its predicate.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "All of the pre-determined acceptance criteria were met with passing results." However, it does not explicitly list the specific numerical acceptance criteria for "Implant strength test to failure" or "Dynamic and static tensile loading." It only lists the tests performed. The acceptance criteria for biocompatibility tests are generally established by regulatory standards (e.g., ISO 10993).
| Test Type | Acceptance Criteria (Not Explicitly Quantified) | Reported Device Performance |
|---|---|---|
| Bench Testing | ||
| Implant strength test to failure | (Implied: Meets or exceeds requirements for meniscal repair devices, likely compared to predicate performance) | Met pre-determined criteria |
| Dynamic and static tensile loading | (Implied: Meets or exceeds requirements for meniscal repair devices, likely compared to predicate performance) | Met pre-determined criteria |
| Biocompatibility Testing | ||
| MEM Elution Using L-929 Mouse Fibroblast Cells | (Implied: Non-cytotoxic, as per ISO 10993 standards) | Biocompatible |
| Guinea Pig Maximization Sensitization Test | (Implied: Non-sensitizing, as per ISO 10993 standards) | Biocompatible |
| Intracutaneous Reactivity Test | (Implied: Non-irritant, as per ISO 10993 standards) | Biocompatible |
| Acute Systemic Injection Test | (Implied: Non-toxic systemically, as per ISO 10993 standards) | Biocompatible |
| Material mediated pyrogen | (Implied: Non-pyrogenic, as per ISO 10993 standards) | Biocompatible |
| Subacute (14 Day) Intraperitoneal Toxicity Study In Rats | (Implied: No significant toxicity, as per ISO 10993 standards) | Biocompatible |
| Subchronic (14 Day) Intravenous Toxicity Study In Rats (including histopathology) | (Implied: No significant toxicity, as per ISO 10993 standards) | Biocompatible |
| Bacterial Mutagenicity Test (Ames Assay) | (Implied: Non-mutagenic, as per ISO 10993 standards) | Biocompatible |
| In Vitro Mouse Lymphoma Assay | (Implied: Non-genotoxic, as per ISO 10993 standards) | Biocompatible |
| In Vivo Mouse Micronucleus Assay | (Implied: Non-genotoxic, as per ISO 10993 standards) | Biocompatible |
| Intramuscular Implantation Tests (2 weeks and 13 weeks) | (Implied: No adverse local tissue reaction, as per ISO 10993 standards) | Biocompatible |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size for the bench and biocompatibility tests. The data provenance is implied to be from internal testing conducted by Ivy Sports Medicine, LLC. The testing is prospective in the sense that it was conducted specifically to support this regulatory submission, but the tests themselves are standard laboratory/bench tests, not clinical studies involving patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is not an AI/diagnostic device that requires expert ground truth for its performance evaluation (e.g., interpreting images). Its performance is evaluated through material science and biological compatibility testing against established standards.
4. Adjudication Method for the Test Set
Not applicable. This concept is typically relevant to clinical trials or AI performance evaluations involving human interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This is a physical medical device (suture retention system), not an AI-powered system designed to assist human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical medical device.
7. The Type of Ground Truth Used
For the bench testing (Implant strength, Dynamic and static tensile loading), the "ground truth" is typically defined by engineering specifications and comparative performance data against the predicate device, or industry standards for mechanical properties.
For biocompatibility testing, the "ground truth" is the established biological response as defined by international standards (e.g., ISO 10993 series) and observed biological effects in the conducted studies.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/machine learning device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird design with three profiles facing right, suggesting a sense of forward movement or progress. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 14, 2016
Ivy Sports Medicine, LLC Mr. John Dichiara Senior Vice President Quality Assurance, Clinical and Regulatory Affairs 545 Penobscot Drive Redwood City, California 94063
Re: K153087
Trade/Device Name: Ivyair Meniscus System, Curved, Ivyair Meniscus System, Straight, Ivyair Meniscus System, Reverse Curved Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable Poly(Ethylene Terephthalate) Surgical Suture Regulatory Class: Class II Product Code: GAT Dated: October 21, 2015 Received: October 26, 2015
Dear Mr. Dichiara:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
David Krause -S
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/0 description: The image shows the logo for Ivy Sports Medicine, LLC. The logo consists of a stylized green image of three leaves on the left, followed by the text "Ivy Sports Medicine, LLC" in black. The text is in a bold, sans-serif font.
SECTION 5
INDICATIONS FOR USE
510(k) Number (if known): K153087
Device Name: IvyAIR Meniscus System
Indications for Use:
The IvyAIR Meniscus System is intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures. The lvyAIR Meniscus System is indicated for use in meniscal repairs and allograft transplant procedures. The lvyAlR Meniscus System device is intended to be used for anchoring the allograft to the meniscal rim during allograft transplant procedures.
Prescription Use
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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SECTION 6
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
510(k) Number: K
Applicant Information:
| Owner Name: | Ivy Sports Medicine, LLC |
|---|---|
| Address: | 545 Penobscot DriveRedwood City, CA 94063 |
| Main Phone: | 650-562-0800 |
| Fax: | 650-562-0808 |
Establishment Registration Number: 2956141
| Contact Person: | John Dichiara |
|---|---|
| Phone: 917-439-2597 | |
| Fax: 650-562-0808 |
Date Prepared: October 21, 2015
Device Information:
- Classification: Class II
- Trade Name: IvyAIR Meniscus System
- Common name: Meniscus Repair Device
- Classification name: Nonabsorbable poly(ethylene terephthalate) surgical suture
- Regulation number: 21 CFR §878.5000
- Product Code: GAT
Predicate Device:
The IvyAlR Meniscus System is substantially equivalent in Intended Use, Fundamental Scientific Technology and Performance to the following legally marketed device in commercial distribution: Smith & Nephew FAST-FIX 360 Meniscal Repair System cleared under K121861.
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Image /page/4/Picture/1 description: The image contains the logo for Ivy Sports Medicine, LLC. The logo features a stylized green graphic to the left of the text. The text "Ivy Sports Medicine, LLC" is written in a bold, sans-serif font.
Device Description:
The IvyAIR Meniscus System is an all-inside meniscus repair device. Each device includes two non-absorbable polymer implants, pre-tied with 2-0 non-absorbable suture and pre-loaded into a needle delivery system. The IvyAIR System is available in three needle configurations: Curved. Straight and Reverse Curve to allow the surgeon a choice for access to the desired zone of the meniscus. The IvyAIR Meniscus System is provided sterile for single use only.
Intended Use:
The IvyAIR Meniscus System is intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures. The IvyAIR Meniscus System is indicated for use in meniscal repairs and allograft transplant procedures. The IvyAIR Meniscus System device is intended to be used for anchoring the allograft to the meniscal rim during allograft transplant procedures.
Comparison to Predicate Device(s):
The IvyAIR Meniscus System has a similar intended use and similar technological characteristics to the predicate device: Smith & Nephew FAST-FIX 360 Meniscal Repair System. Any differences identified do not raise new questions of safety or effectiveness, as supported by biomechanical, biocompatibility and bench testing.
Technological Characteristics/Performance Data:
The IvyAIR Meniscus System is substantially equivalent to the predicate device in intended use, fundamental scientific technology, and performance specifications. Design verification testing was performed to verify that the performance of the IvvAlR Meniscus System remains substantially equivalent to the predicate device. The device has been tested for biocompatibility according to ISO10993-1 and was determined to be biocompatible. Testing performed on the IvyAIR Meniscus System included the following:
| Bench Testing | Biocompatibility Testing |
|---|---|
| Implant strength test to failure | MEM Elution Using L-929 Mouse Fibroblast Cells |
| Dynamic and static tensile loading | Guinea Pig Maximization Sensitization Test |
| Intracutaneous Reactivity Test | |
| Acute Systemic Injection Test | |
| Material mediated pyrogen | |
| Subacute (14 Day) Intraperitoneal Toxicity Study In Rats | |
| Subchronic (14 Day) Intravenous Toxicity Study In Rats | |
| including histopathology | |
| Bacterial Mutagenicity Test (Ames Assay) | |
| In Vitro Mouse Lymphoma Assay | |
| In Vivo Mouse Micronucleus Assay | |
| Intramuscular Implantation Tests (2 weeks and 13 weeks) |
All of the pre-determined acceptance criteria were met with passing results.
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Image /page/5/Picture/1 description: The image shows the logo for Ivy Sports Medicine, LLC. The logo consists of a stylized green image of leaves on the left, followed by the text "Ivy Sports Medicine, LLC" in black. The text is in a bold, sans-serif font.
Clinical Testing:
Clinical evaluation is not required for this device.
Substantial equivalence:
The IvyAIR Meniscus System has the following similarities to the Smith & Nephew FAST-FIX 360 Meniscal Repair System predicate device cleared under K121861.
- has the same intended use and indication for use,
- . has the same technological characteristics,
- . has the same principles of operation,
- . has equivalent performance characteristics, and
- . has the same sterilization process.
Summary
In summary, the IvyAIR Meniscus System subject to this submission is as safe and effective as the Smith & Nephew FAST-FIX 360 Meniscal Repair System. It has the same indication for use, the same technological characteristics, and the same principles of operation as the Smith & Nephew FAST-FIX 360 Meniscal Repair System. The differences between the IvyAIR Meniscus System and the Smith & Nephew FAST-FIX 360 Meniscal Repair System raise no new issues of safety or effectiveness. Performance data demonstrate that the IvyAlR Meniscus System is as safe and effective as the Smith & Nephew FAST-FIX 360 Meniscal Repair System and is therefore substantially equivalent to the predicate device.
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.