(143 days)
Each Pillar Nasal Implant is indicated for the augmentation or reconstruction of nasal eminence deficiencies, whether congenital or acquired by trauma or disease.
The Pillar Nasal Implant is made from identical liquid elastomer materials and manufacturing processes as the predicate device. 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.
This document is a 510(k) summary for the Pillar Nasal Implant, a medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving performance against specific acceptance criteria. Therefore, most of the information requested in your prompt is not available in these documents.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
This document does not define specific acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity) for the device. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Silimed, Inc Elifal nasal implant).
The "performance" reported is primarily related to physical and chemical properties and intended use, aligning with the predicate device:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Material Composition | Identical liquid elastomer materials (Nusil's MED 4211 unrestricted silicone fluid from Nusil Technologies, Inc.) as the predicate device. |
| Manufacturing Process | Identical manufacturing processes as the predicate device. |
| Durometer (Hardness) | Ranges from 5 to 30 Shore A (consistent with predicate). |
| Appearance | Clear to opaque (consistent with predicate). |
| Tensile Strength | Averages 700 psi (consistent with predicate). |
| Elongation | Over 400 percent (consistent with predicate). |
| Intended Use | To augment or reconstruct facial nasal deformities caused by facial trauma or congenital defects (identical to predicate). |
| Surgical Methods | Implanted using the same accepted surgical methods of the predicate device. |
2. Sample size used for the test set and the data provenance:
- Not applicable. This document describes a 510(k) submission, which relies on demonstrating substantial equivalence based on material, manufacturing, and intended use comparison to a legally marketed predicate device. It does not involve a "test set" of patient data in the way an AI/ML device would. No clinical study data is presented to prove performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. As above, there is no "test set" or "ground truth" establishment in the context of clinical performance evaluation for this 510(k) submission.
4. Adjudication method for the test set:
- Not applicable.
5. 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. This device is a physical implant, not an AI/ML diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable.
7. The type of ground truth used:
- Not applicable. The "ground truth" for this submission would primarily be the established physical, chemical, and functional characteristics of the predicate device and the demonstration that the Pillar Nasal Implant matches these characteristics.
8. The sample size for the training set:
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable.
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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.
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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
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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
§ 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.