(177 days)
Indicated for:
- Nasal soft-tissue and cartilage reconstruction
The Ethicon Inc. PDS Flexible Plates are indicated for:
– Nasal soft-tissue and cartilage reconstruction
PDS Flexible Plate are made of poly-p-dioxanone, an aliphatic polyester which is manufactured by polymerisation of the monomer p-dioxanone. PDS Flexible Plate are dyed with D+C violet # 2 (Color index Number 60725). PDS Flexible Plate are available in various film thicknesses, some of which are also perforated. PDS Flexible Plate can be trimmed to suit the anatomical conditions. The PDS Flexible Plate is a sterile, single use device.
This 510(k) premarket notification describes a medical device, the PDS Flexible Plate, which is a synthetic absorbable polymer indicated for nasal soft-tissue and cartilage reconstruction. The submission focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study results with specific acceptance criteria and performance metrics typically found for novel AI/ML-driven diagnostics.
Therefore, many of the requested sections regarding AI/ML study design, reader studies, and detailed performance metrics are not applicable to this 510(k) submission. This document primarily reports on bench-top and preclinical evaluations to support substantial equivalence.
Here's the information that can be extracted and a clear statement of what is not applicable:
Acceptance Criteria and Device Performance (Based on Substantial Equivalence)
The acceptance criteria for this 510(k) submission are not explicitly stated in terms of quantitative performance metrics for a diagnostic or AI device. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices. This means the device must show comparable characteristics in relevant areas and raise no new issues of safety or effectiveness.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Similar Intended Use | "The PDS Flexible Plate has the same intended use... as its predicate devices." (Page 2) |
| Similar Indications for Use | "...and similar indications for use... as its predicate devices." (Page 2) |
| Similar Technological Characteristics | "PDS Flexible Plate underwent an extensive performance testing program to support that the PDS Flexible Plate fulfill the device requirements as defined in user specifications, function as intended, and are substantially equivalent to the predicate devices." (Page 2) |
| Similar Principles of Operation | "...and principles of operation as its predicate devices." (Page 2) |
| No New Issues of Safety or Effectiveness | "The technological differences between the PDS Flexible Plate and the predicate devices raise no new issues of safety or effectiveness." (Page 2) |
| Comparable Physical Properties (Thickness, Tensile, Flexibility) | "Bench top testing compared the device to predicate devices in thickness, tensile properties and flexibility and was shown to have comparable characteristics." (Page 2) |
| Achieve Intended Use (Preclinical Evaluation) | "Preclinical evaluations with the device and its predicates demonstrate the device's ability to achieve the intended use and support substantial equivalence." (Page 2) |
The following sections are NOT APPLICABLE as this is a 510(k) submission for a non-AI/ML implantable medical device, not a diagnostic or AI-powered system.
- Sample size used for the test set and the data provenance: Not applicable. Performance testing was "bench top" and "preclinical evaluations" and not based on a test set of patient data as for an AI/ML diagnostic.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML diagnostic test set is not relevant for this device.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an AI/ML diagnostic. For this device, "ground truth" relates to the physical and biological performance in preclinical models or bench tests demonstrating its ability to function as intended and comparably to predicates.
- The sample size for the training set: Not applicable. There is no training set for an AI/ML model for this device.
- How the ground truth for the training set was established: Not applicable.
Summary of Relevant Information:
- Device Name: PDS Flexible Plate
- Intended Use: Nasal soft-tissue and cartilage reconstruction.
- Study Type: Bench top testing and preclinical evaluations to support substantial equivalence.
- Primary Objective of Study: To demonstrate that the PDS Flexible Plate fulfills device requirements, functions as intended, and is substantially equivalent to predicate devices (Orthosorb Pin, PDS Suture, MACROPORE ENT Reconstruction Film, LactoSorb Sheets, Silmax Sheeting).
- Key Findings: The device demonstrated comparable characteristics to predicate devices in thickness, tensile properties, and flexibility. Preclinical evaluations showed the device's ability to achieve intended use.
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K092590 page 1/2
510(k) SUMMARY Ethicon, Inc. PDS* Flexible Plate
FEB 1 7 2010
Submitter's Name, Address, Telephone Number:
Ethicon, Inc., Ethicon Products Route 22 West P.O. Box 151 Somerville, NJ 08876-0151
Phone: (908) 218-3275 Facsimile: (908) 218-2595
Date Prepared:
Date Prepared: August 21th, 2009
Contact Person:
·
Leslie Young Sr. Regulatory Specialist
Trade Name of Device and Name/Address of Sponsor:
PDS* Flexible Plate Ethicon, Inc. Route 22 West P.O. Box 151 Somerville, NJ 08876
Common or Usual Name:
Polymer, ear, nose and throat, synthetic, absorbable
Classification Name:
Polymer, ear, nose and throat, synthetic, absorbable ; 21 CFR § 874.3620
Classification Code:
NHB; Class II
- Trademark of Ethicon, Inc.
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K092590 Page 2/2
Predicate Devices:
Ethicon Endo-Surgery's Orthosorb Pin (K901456)
Ethicon's PDS* Suture (N18331)
Macropore Biosurgery, Inc.'s MACROPORE ENT Reconstruction Film (K012769)
LactoSorb Sheets (K992158)
Silmax Sheeting (K954382)
Intended Use / Indications for Use
Indicated for:
- Nasal soft-tissue and cartilage reconstruction
Technological Characteristics
PDS Flexible Plate are made of poly-p-dioxanone, an aliphatic polyester which is manufactured by polymerisation of the monomer p-dioxanone. PDS Flexible Plate are dyed with D+C violet # 2 (Color index Number 60725). PDS Flexible Plate are available in various film thicknesses, some of which are also perforated. PDS Flexible Plate can be trimmed to suit the anatomical conditions. The PDS Flexible Plate is a sterile, single use device.
Performance Data
PDS Flexible Plate underwent an extensive performance testing program to support that the PDS Flexible Plate fulfill the device requirements as defined in user specifications, function as intended, and are substantially equivalent to the predicate devices. Bench top testing compared the device to predicate devices in thickness, tensile properties and flexibility and was shown to have comparable characteristics. Preclinical evaluations with the device and its predicates demonstrate the device's ability to achieve the intended use and support substantial equivalence.
Substantial Equivalence
The PDS Flexible Plate has the same intended use, and similar indications for use, technological characteristics, and principles of operation as its predicate devices. The technological differences between the PDS Flexible Plate and the predicate devices raise no new issues of safety or effectiveness. Performance data and preclinical evaluations demonstrate that the device is as safe and effective as the predicate devices for the stated use. Thus, the PDS Flexible Plates are substantially equivalent
- Trademark of Ethicon, Inc.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
FEB 1 7 2010
Ethicon, Inc. % Ms. Leslie Young Senior Regulatory Specialist Route 22 West P.O. Box 151 Somerville, New Jersey 08876-0151
Re: K092590
Trade/Device Name: PDS™ Flexible Plate Regulation Number: 21 CFR 874.3620 Regulation Name: Ear, nose and throat synthetic polymer material Regulatory Class: Class II Product Code: NHB Dated: January 18, 2010 Received: January 19, 2010
Dear Ms. Young:
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
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Page 2 - Ms. Leslie Young
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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" (21CFR 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 vours.
Chibaro Buelho
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): K092590 Device Name: PDS* Flexible Plates Indications for Use:
The Ethicon Inc. PDS Flexible Plates are indicated for:
– Nasal soft-tissue and cartilage reconstruction
- Trademark of Ethicon, Inc.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
Daniel Krone for MXM
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K092590
§ 874.3620 Ear, nose, and throat synthetic polymer material.
(a)
Identification. Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.(b)
Classification. Class II.