(143 days)
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Not Found
No
The summary describes a physical implant made of silicone elastomer and does not mention any software, algorithms, or data processing that would indicate AI/ML.
No.
The device is indicated for augmentation or reconstruction of nasal deficiencies, which is a structural or aesthetic purpose, not primarily to treat a disease or condition in a therapeutic manner.
No
Explanation: The device is an implant for augmentation or reconstruction, not for diagnosis.
No
The device description clearly states it is a physical implant made from liquid elastomer materials, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description and Intended Use: The description clearly states the Pillar Nasal Implant is a physical implant made of silicone elastomer. Its intended use is for the augmentation or reconstruction of nasal deficiencies. This is a surgical implant placed inside the body.
The information provided describes a surgically implanted device, not a device used for testing biological samples in a lab setting.
N/A
Intended Use / Indications for Use
The intended use of the Pillar Nasal Implant is to augment or reconstruct facial nasal deformities caused by facial trauma or congenital defects. The Pillar Nasal Implant is implanted using the same accepted surgical methods of the predicate device.
Each Pillar Nasal Implant is indicated for the augmentation or reconstruction of nasal eminence deficiencies, whether congenital or acquired by trauma or disease.
Product codes
FZE
Device Description
The Pillar Nasal Implant is made from identical liquid elastomer materials and manufacturing processes as the predicate device. The physical properties of this device are the same as the predicate device in that equivalent materials will be used in manufacturing. The raw materials are Nusil's MED 4211 unrestricted silicone fluid from Nusil Technologies, Inc. The durometers or hardness (shore A) of each implant will range from 5 to 30. The appearance is described as clear to opaque. Tensile strength averages 700 psi and the percent of elongation is over 400 percent. Raw material are certified and tested to comply with the requirements of the manufacturer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nasal, facial nasal
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)
Silimed. Inc Elifal nasal amarketed by Silimed, LLC.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.3680 Nose prosthesis.
(a)
Identification. A nose prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the nasal dorsum.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the date November 22, 1999, written in a simple, sans-serif font. Below the date, the words "PILLAR SURGICAL" are printed in a larger, bolder font. The word "PILLAR" is underlined, and the two words are stacked on top of each other. To the left of the text is a dark, vertical graphic.
Enclosure F
510(k) Summary
Substantial Equivalence
The Pillar Nasal Implant is substantially equivalent to the Silimed. Inc Elifal nasal amarketed by Silimed, LLC. The Pillar Nasal Implant is made from identical liquid elastomer materials and manufacturing processes as the predicate device.
Intended Use
The intended use of the Pillar Nasal Implant is to augment or reconstruct facial nasal deformities caused by facial trauma or congenital defects. The Pillar Nasal Implant is implanted using the same accepted surgical methods of the predicate device.
Labeling
The labeling for this device will comprise a label for the inner package and a label for the outer box. Catalog numbers and sizes will package and a ruaged on the labels. A "Package Insert" will contain instructions for sterilization and indications for use. Product promotional material will depict size, shape and material firmness of the implant.
Physical and Chemical Properties
The physical properties of this device are the same as the predicate device in that equivalent materials will be used in manufacturing. The raw materials are Nusil's MED 4211 unrestricted silicone fluid from Nusil Technologies, Inc. The durometers or hardness (shore A) of each implant will range from 5 to 30. The appearance is described as clear to opaque. Tensile strength averages 700 psi and the percent of elongation is over 400 percent. Raw material are certified and tested to comply with the requirements of the manufacturer. For more information, see FDA master-file MAF 612.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized symbol that resembles three abstract human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 22 1999
Mr. Rob Fritzenkotter Pillar Surgical P.O. Box 8141 La Jolla, California 92038
K992242 Re: Trade Name: Nasal, Dorsal Columella, and Nasal Dorsum Implant Regulatory Class: II Product Code: FZE Dated: November 4, 1999 Received: November 5, 1999
Dear Mr. Fritzenkotter:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is 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 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device 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 requirement, 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 device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Rob Fritzenkotter
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device 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 device, 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,
Neil R.P. Ogden for
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) NUMBER (IF KNOWN):
DEVICE NAME:
INDICATIONS FOR USE:
Each Pillar Nasal Implant is indicated for the augmentation or reconstruction of nasal eminence deficiencies, whether congenital or acquired by trauma or disease.
NRO for
(Division Sign-Off)
Division of General Restorative Devices K992242
510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
942242
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter-Use (Optional Format 1