(75 days)
No
The summary describes a simple saline solution in a vial for sputum induction, with no mention of any computational or analytical capabilities, let alone AI/ML.
No
The device, sodium chloride solutions, is used for the induction of sputum production for specimen collection, which is a diagnostic procedure, not a therapeutic treatment.
No
This device is a saline solution used to induce sputum production for specimen collection, which is a preparatory step for diagnosis, not a diagnostic act in itself.
No
The device description clearly states it is a solution contained in a polyethylene vial, which is a physical product, 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 for the induction of sputum production for specimen collection. This is a process to help a patient produce a sample, not a test performed on a biological sample to diagnose a condition.
- Device Description: The device is a solution of sodium chloride used with a nebulizer. This is a therapeutic or procedural aid, not a reagent or instrument used for analyzing a sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
IVD devices are specifically designed to be used in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to facilitate the collection of a specimen, not to perform a diagnostic test on it.
N/A
Intended Use / Indications for Use
Dey Vial Sodium Chloride 3% and 10% are used in conjunction with a nebulizer for the induction of sputum production where specimen collection is indicated.
Product codes
73 CAF
Device Description
DEY-PAK® Sodium Chloride Solution 3% and 10% solutions are contained in a 15 mL polyethylene vial. The vials have a tear-off top and a lower tab for displaying the lot number and expiration date. One side of the vial has pressure sensitive label and the other side is blank. The vials are supplied in cartons of 50 vials.
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5630 Nebulizer.
(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows a logo with the letters "DEY" in bold, sans-serif font. Above the letters is an arc shape, and below the letters is a curved line that forms a sort of cradle. The logo is simple and monochromatic, with a clean and modern design.
OCT - 8 1997 PREMARKET NOTIFICATION [510(K)} SUMMARY
Dev Laboratories LP 2751 Napa Valley Corporate Drive Napa, CA 94558 (707) 224-3200 Fax: (707) 224-0791 Contact Person: Allan S. Kaplan, R.P., Ph.D., Vice President of Technical Affairs Date Summary Prepared: July 18, 1997
- DEY-PAK® Sodium Chloride Solution 3% Trade Name: DEY-PAK® Sodium Chloride Solution 10%
- Sodium Chloride Solution 3% Common Name: Sodium Chloride Solution 10%
- Classification: Class II
- DEY-VIAL® Sodium Chloride, USP Sterile 10 mL (K880411) Equivalence Claim: Arm-A-Vial (Armour, K841988, K841988-A, K841989, K841989-A) Dis-Pos-Vial (Parke-Davis) Redipak (Wyeth)
- Device Description: DEY-PAK® Sodium Chloride Solution 3% and 10% solutions are contained in a 15 mL polyethylene vial. The vials have a tear-off top and a lower tab for displaying the lot number and expiration date. One side of the vial has pressure sensitive label and the other side is blank. The vials are supplied in cartons of 50 vials.
Intended Use: DEY-PAK® Sodium Chloride Solution 3% and 10% are used in conjunction with a nebulizer. The contents of the vial is to be dispensed, as prescribed, into a nebulizer cup. The solution is then inhaled to induce sputum.
000112
Image /page/0/Picture/12 description: The image shows a close-up, black-and-white drawing of a pinecone. The pinecone is depicted with detailed scales that overlap each other, creating a textured surface. The drawing captures the natural, organic shape of the pinecone, highlighting its intricate structure.
1
Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing right, stacked on top of each other. The profiles are connected by a flowing ribbon-like shape at the bottom. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
OCT - 8 1997
Allan S. Kaplan, R.P., Ph.D. Dey Laboratories 2751 Napa Valley Corporate Drive Napa, California 94558
Re: K972778 DEY-PAK® Sodium Chloride Solution, USP, Sterile, 3% and 10% Regulatory Class: II (two) Product Code: 73 CAF Dated: July 24, 1997 Received: July 25, 1997
Dear Dr. Kaplan:
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, Druq, 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 reqistration, listinq 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 requlations 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 (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.
2
Page 2 - Allan S. Kaplan, R.P., Ph.D.
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) 594-4648. 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,
Thomas J. Collelon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上
3
Page_1___of__1__
510(k) Number (if known): __ K972778
Device Name: Dey Vial Sodium Chloride 3% and 10%
Indications For Use:
Dey Vial Sodium Chloride 3% and 10% are used in conjunction with a nebulizer for the induction of sputum production where specimen collection is indicated.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number | __________________________ |
Prescription Use_v OR Over-The-Counter Use_
(Per 21 CFR 801.109) (Optional Format 1-2-96)