(85 days)
Not Found
No
The device description and intended use focus solely on the material properties and anatomical applications of silicone elastomer sheeting. There is no mention of any computational analysis, image processing, or learning algorithms.
Yes.
The device is used for various medical applications, including wound dressings, repair of body parts, and temporary facilitation of osteogenesis, which are all therapeutic interventions aimed at treating or alleviating medical conditions.
No
Explanation: The document describes Durasil I and Durasil II as silicone elastomer sheeting used for surgical repairs, wound dressings, and other short-term and long-term medical applications. These are materials for treatment and repair, not for diagnosing conditions.
No
The device description clearly states it is made from silicone elastomer sheeting, which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended uses listed are all related to surgical procedures and direct implantation or application within the body for structural support, wound management, tissue regeneration, etc. These are therapeutic or supportive functions, not diagnostic ones.
- Device Description: The device is described as silicone elastomer sheeting used for physical applications within the body. This aligns with a medical device used for treatment or support, not for analyzing samples from the body to diagnose a condition.
- Lack of Diagnostic Function: There is no mention of the device being used to test or analyze samples (blood, urine, tissue, etc.) to provide information about a patient's health status or diagnose a disease.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is entirely in vivo (within the body) or for external wound management.
N/A
Intended Use / Indications for Use
Durasil I (Short Term) nasal splinting, wound dressings, wound drains, covering for gastroschisis, suture bolsters, scar coverings, laboratory uses, temporary facilitation of osteogenesis, and guided tissue regeneration between the teeth and gingival margin, or external ear canal for example, temporary joint spacers, and other short term uses according to the surgeon's determination.
Durasil II (Long Term) Nonreinforced - Tympanic membrane repair, dural covering .005 inch, nasal septal repair, tendon anastomosis, neural repair - .007 inch. correction of strabismus .010 inch, repair - .020 inch, orbital floor repair .040inch, galea hemodialysis shunt anchors .060. Reinforced - Facilitation of osteogenesis .007inch, repair of urethral strictures .007inch, staged repair of omphalocoel .020inch, repair of orbital floor fractures .040inch.
Product codes
MIB
Device Description
Durasil I and Durasil II Silicone Elastomer Sheeting are made from a biocompatible silicone high consistency rubber, HCRP-50 made by Applied Silicone and Nusil Technologies' MED 4750. There is essentially no difference between these two products saving for the short term and long term indications which are for marketing considerations only. Durasil I and II are available in polyester mesh reinforced and nonreinforced in a variety of thicknesses. The silicone elastomer used to make this product have met all Biocompatibility Guidelines set for by FDA for the replacement of Dow Corning Products. These biomaterial standards exceed or meet Class VI USP Standards in that they include Teratogenicity, Mutagenicity, Carcinogenicity and Toxicity Testing. These referenced material characterizations are found in Applied Master File - MAF 607.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasal, wound, joint, teeth, gingival margin, external ear canal, tympanic membrane, dura, tendon, neural, strabismus, orbital floor, galea, hemodialysis shunt, urethral, omphalocoel
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
HANSON MEDICAL INC. 19325 58TH PL. NE. Seattle WA 98155 (425) 481 2185 510(k) Submission Durasil Sheeting
DEC 2 4 1997
TAB H
510 (K) SUMMARY
PRODUCT DESCRIPTION
Durasil I and Durasil II Silicone Elastomer Sheeting are made from a biocompatible silicone high consistency rubber, HCRP-50 made by Applied Silicone and Nusil Technologies' MED 4750. There is essentially no difference between these two products saving for the short term and long term indications which are for marketing considerations only. Durasil I and II are available in polyester mesh reinforced and nonreinforced in a variety of thicknesses. The silicone elastomer used to make this product have met all Biocompatibility Guidelines set for by FDA for the replacement of Dow Corning Products. These biomaterial standards exceed or meet Class VI USP Standards in that they include Teratogenicity, Mutagenicity, Carcinogenicity and Toxicity Testing. These referenced material characterizations are found in Applied Master File - MAF 607.
SUBSTANTIAL EQUIVALENCE
These products are substantially equivalent to Duralastic I and II made by Allied Biomedical's Sheeting (K971480). Because Durasil Sheeting is made from the same materials using the same processes and made in the same sizes and thicknesses for the same intended use, it is SE to the predicate devices.
INTENDED USES
Durasil I and II are intended for a variety of medical purposes both in short term and long term applications. For short term application this list includes nasal splinting, wound dressings, scar coverings, temporary joint shims, and laboratory uses. For long term use this list includes nasal septal repair, orbital floor reconstruction, tympanic membrane repair, dialysis shunt anchoring, duramater repair, staged repair of omphalocoel, lengthening of extraocular muscles, tendon and nerve anastomosis, facilitation of osteogenesis or guided tissue regeneration, and other uses deemed appropriate by the using surgeon. Silicone sheeting has been in use for over 30 years and the uses are myriad. Hanson Medical Inc. advises surgeons to consult the literature before utilizinq
1
TAB H 510(k) Summary
Durasil Sheeting for any purpose in the package inserts.
PHYSICAL AND CHEMICAL PROPERTIES
Durasil Sheeting is a vulcanized calendared cured rubber of a 45 -55
Durometer hardness (Shore A). It has an elonqation of 800 percent with a tensile strength of 1600 psi and a tear strength of 190 psi (Tear Die C). The elasticity is greatly reduced in the polyester reinforced sheets. The specific gravity is 1.16. Chemically Durasil II are made from HCRA-50, an Applied and a I Silicone dimethylpolysiloxane and from Nusil Technologies MED 4750. For details on the foregoing chemical and physical properties consult Masterfile MAF 607 of Applied Silicone and MAF 500 of Nusil Technoloqies.
STERILIZATION CYCLE
Durasil I and II sheeting are sterilized via gamma radiation 2.5 -4.2 Megarads. The validation of this cycle was performed by STI Corporation of Brea California. STI uses Sterigenics Inc. as the contract gamma radiation sterilizer. The validation uses Method 1 Testing as defined in the ANSI/AAMI/ISO 11137-1994 "Sterilization of Health Care Products - Requirements for Validation and Routine Control - Radiation Sterilization."
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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 stylized eagle with three stripes forming its body and wing. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 4 1997
Mr. Gerald Hanson Regulatory Affairs HANSON MEDICAL INC. 19325 58th Place NE Seattle, Washington 98155
Re: K973730 Trade Name: Durasil I and Durasil II Regulatory Class: Unclassified Product Code: MIB Dated: September 27, 1997 Received: September 30, 1997
Dear Mr. Hanson:
We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submissions does not affect any obligation you might have under sections 531 through 542 of the Act for
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Page 2 - Mr. Gerald Hanson
devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K 973730
INTENDED USE FORM
Page 1 of 1
510 (k) Number (if known) K973730
ે જિલ્લાન Device Name: Silicone Elastomer Sheeting Durasil I and II
Indications For Use:
Durasil I (Short Term) nasal splinting, wound dressings, wound drains, covering for gastroschisis, suture bolsters, scar coverings, laboratory uses, temporary facilitation of osteogenesis, and guided tissue regeneration between the teeth and gingival margin, or external ear canal for example, temporary joint spacers, and other short term uses according to the surgeon's determination.
Durasil II (Long Term) Nonreinforced - Tympanic membrane repair, 想: dural covering .005 inch, nasal septal repair, tendon anastomosis, neural repair - . 007 inch. correction of strabismus .010 inch, repair - . 020 inch, orbital floor repair . 040inch, galea hemodialysis shunt anchors .060. Reinforced - Facilitation of osteogenesis . 007inch, repair of urethral strictures . 007inch, staged repair of omphalocoel .020inch, repair of orbital floor fractures .040inch.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
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Over-The-Counter-Use
(Optional Format 1-2-96)
Clen with
Sign 658
Division of Grievance Redressive Dave,
EAN Number: K973730