(177 days)
Not Found
No
The device description and performance studies focus on the material properties and mechanical performance of a resorbable plate, with no mention of AI or ML capabilities.
Yes
The PDS Flexible Plates are used for nasal soft-tissue and cartilage reconstruction, which is a therapeutic intervention.
No
Explanation: The device description and intended use clearly state that the PDS Flexible Plates are used for reconstruction (nasal soft-tissue and cartilage), which is a treatment or restorative function, not a diagnostic one. There is no mention of identifying or detecting a disease or condition.
No
The device description explicitly states the device is made of poly-p-dioxanone and is a physical plate, indicating it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "Nasal soft-tissue and cartilage reconstruction." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The device is a physical implantable material (flexible plates made of poly-p-dioxanone) used for structural support during surgery.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) to diagnose a condition, monitor a disease, or screen for health issues.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic purposes. This device is used in vivo (inside the body) for reconstruction.
N/A
Intended Use / Indications for Use
Indicated for:
- Nasal soft-tissue and cartilage reconstruction
The Ethicon Inc. PDS Flexible Plates are indicated for:
– Nasal soft-tissue and cartilage reconstruction
Product codes (comma separated list FDA assigned to the subject device)
NHB
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nasal soft-tissue and cartilage
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K901456, N18331, K012769, K992158, K954382
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
1
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.
2
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
3
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
4
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