(29 days)
Not Found
Not Found
No
The summary describes a physical implant and does not mention any software, algorithms, or AI/ML terms.
Yes
The device, implants used to augment or reconstruct the nose in rhinoplasty, is a therapeutic device because its intended use is to treat or correct a medical condition or anatomical feature.
No
The device is described as an implant used to augment or reconstruct the nose in rhinoplasty, which is a therapeutic intervention, not a diagnostic one.
No
The device description is not found, but the intended use clearly describes "implants," which are physical devices, 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 to "augment or reconstruct the nose in rhinoplasty." This describes a surgical procedure performed directly on a patient's body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status, disease, or condition based on sample analysis.
- Use in a laboratory setting for diagnostic purposes.
This device is a surgical implant, which is a type of medical device used in vivo (within the body) during a surgical procedure. IVDs are used in vitro (outside the body) to analyze samples.
N/A
Intended Use / Indications for Use
Surgical Technology Laboratories, Inc. Nasal Dorsal Series implants are intended to be used to augment or reconstruct the nose in rhinoplasty.
Product codes
FZE
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
nose
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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): 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.
Not Found
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.
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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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top and bottom. Inside the circle is a stylized symbol featuring three abstract human profiles or faces, which are often interpreted as representing the department's focus on people and health.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 20 1998
Mr. Richard T. Nock Vice President Surgical Technology Laboratories, Inc. 1588 East 40th St. Cleveland, Ohio 44103
Re: K983755 Trade Name: Nasal Dorsal Series Regulatory Class: II Product Code: FZE Dated: October 16, 1998 Received: October 22, 1998
Dear Mr. Nock:
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 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). 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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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. Richard T. Knock
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/dsma/dsmamain.html".
Sincerely yours,
Jocelyn
- 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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Image /page/2/Picture/0 description: The image shows the logo for Surgical Technology Laboratories, Inc. The logo is in bold, black font. The address of the company is listed as 1588 East 40th St. Cleveland, Ohio 44103. The date '98-11-19 11:35 SURGIFORM is printed at the top of the image.
Image /page/2/Picture/1 description: The image shows a series of bold, black handwritten characters against a white background. The characters appear to be 'KA69755', with some additional markings above the last two digits. The style of writing is thick and somewhat stylized, giving the impression of a quickly written or stylized font.
(216) 431-5055
510(k) Number (if known): K_983755
Device Name: Nasal Dorsal Series
Indications for Use:
Surgical Technology Laboratories, Inc. Nasal Dorsal Series implants are intended to be used to augment or reconstruct the nose in rhinoplasty.
Prescription Use
(Per 21 CFR 801.109)
Oceano
of General Restorative Devices 4837