(82 days)
Not Found
Not Found
No
The provided 510(k) summary contains no information about the device description, intended use, or any mention of AI, ML, or related concepts.
No
The provided information is completely empty and lacks any description of the device's function or intended use, making it impossible to determine if it is a therapeutic device.
No
Explanation: The provided information does not contain any details about the device's intended use, indications for use, or performance studies, which are crucial for determining if it is a diagnostic device. All fields are marked as "Not Found."
Unknown
The provided 510(k) summary is completely empty, offering no information about the device's nature, components, or function. Therefore, it's impossible to determine if it's a software-only medical device.
Based on the information provided, it is impossible to determine if this device is an IVD.
The document contains "Not Found" for all the key sections that would typically describe a medical device, including its intended use, description, and any mention of diagnostic processes.
To determine if it's an IVD, you would need information about:
- Intended Use: Does it analyze samples taken from the human body (like blood, urine, tissue)?
- Device Description: What does the device actually do?
- Any mention of diagnostic testing: Does it perform tests to diagnose diseases or conditions?
Without any of this information, we cannot classify the device.
N/A
Intended Use / Indications for Use
Not Found
Product codes
LCN
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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): 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.
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
§ 872.6855 Manual toothbrush.
(a)
Identification. A manual toothbrush is a device composed of a shaft with either natural or synthetic bristles at one end intended to remove adherent plaque and food debris from the teeth to reduce tooth decay.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.
0
Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized caduceus, a symbol of medicine and health. The caduceus is composed of three wavy lines that resemble a staff with two snakes coiled around it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG | | | 1998
BreathAid, LCC C/O Mr. J. Douglas Nunn, Jr. Nelson Mullins Riley & Scarborough, L.L.P. Keenan Building, Third Floor 1330 Lady Street P.O. Box 11070 (29211) Columbia, South Carolina 29201
Re : K981808 BreathAid Tonque Scraper Trade Name: Requlatory Class: Unclassified Product Code: LCN May 13, 1998 Dated: Received: May 21, 1998
Dear Mr. J. Douglas Nunn, Jr.:
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 The general controls provisions of the Act 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 Requlations, Title 21, Parts 800 to 895. ਚ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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
1
Page 2 - Mr. J. Douglas Nunn, Jr.
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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) 594-4692. 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,
S. Autman for
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
09:38
ODE DGRD
002
Page of
510(k) Number (if known): K981808
8301 827 4348
Device Name:
08/04/98
Indications For Use:
| Post-it® Fax Note | 7671 | Date | 8/5 | # of pages | 1 |
|---|---|---|---|---|---|
| To | MYRA BROWN | From | J.D. NUNN | ||
| Co./Dept. | Co. | N&R+S | |||
| Phone # | Phone # | ||||
| Fax # | 301-827-9349 | Fax # | 12732/0001 |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODDE)
Susan Rumsey
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 194 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Forman 1-2-96)