(186 days)
Not Found
No
The device description is for a simple saline solution in an ampule, and there are no mentions of AI, ML, or any related technologies.
No
The device is described as "Sodium Chloride Injection, 0.9%, USP, 10 mL Ampule" and its indicated use is "only for use in flushing compatible intravenous tubing systems and in dwelling intravascular access devices." This function (flushing/maintaining patency) is for device maintenance, not for treating a disease or condition in a patient.
No
The Intended Use section describes the device as being used for flushing intravenous tubing systems and dwelling intravascular access devices, which are therapeutic or maintenance activities, not diagnostic.
No
The device description clearly states it is a physical product, "Sodium Chloride Injection, 0.9%, USP, 10 mL Ampule," which is a drug/device combination product, not a software-only medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for flushing and dwelling in intravenous tubing systems and intravascular access devices. This is a direct interaction with the patient's circulatory system, not the examination of specimens in vitro (outside the body).
- Device Description: The device is a Sodium Chloride Injection, which is a pharmaceutical product administered directly to the patient.
- Lack of IVD Characteristics: The description lacks any mention of analyzing biological specimens, using reagents for diagnostic purposes, or providing diagnostic information.
IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening. This device's function is entirely within the patient's body.
N/A
Intended Use / Indications for Use
The device is indicated only for use in flushing compatible intravenous tubing systems and in dwelling intravascular access devices. Not to be used for any other purposes.
Product codes
NGT
Device Description
Spectra Medical's, Sodium Chloride Injection, 0.9%, USP, 10 mL Ampule
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)
There has been no change to the performance characteristics of the device system.
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
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).
0
MAR 20 2009
510(k) Summary
for
Spectra Medical's Device, Sodium Chloride Injection, 0.9%, USP, 10 mL Ampule
1. DATE PREPARED
March 16, 2009
2. SPONSOR INFORMATION
A. NAME, ADDRESS AND TELEPHONE/FACSIMILE NUMBER
Spectra Medical Devices, Inc. 260 F & H Fordham Road Wilmington, MA 01887
Contact Person:
Mr. Agustin Turriza
(978) 657-0889 x 225 (telephone) (978) 657-4339 (facsimile)
B. OUTSIDE REGULATORY COUNSEL
Foley & Lardner LLP 3000 K St., NW Suite 500 Washington, DC 20007
Contact Person: David L. Rosen, B.S. Pharm., J.D.
(202) 672-5430 (telephone) (202) 672-5399 (facsimile) drosen@foley.com
1
DEVICE NAME 3.
| Proprietary Name: | Sodium Chloride Injection, 0.9%, USP
10 mL Ampule |
|--------------------------------------|-------------------------------------------------------------------|
| Common/Usual Name: | Sodium Chloride Injection, 0.9%, USP
10 mL Ampule |
| Classification Names
and numbers: | Saline, Vascular Access Flush
Class II, General Hospital, NGT. |
DEVICE DESCRIPTION AND INTENDED USE 4.
Spectra Medical's, Sodium Chloride Injection, 0.9%, USP, 10 mL Ampule
Indications for Use:
The device is indicated only for use in flushing compatible intravenous tubing systems and in dwelling intravascular access devices. Not to be used for any other purposes.
న. PREDICATE DEVICE
K023740 - Syrex Pre-filled Syringe with 0.9% Sodium Chloride a.
Substantial Equivalence Comparison b.
Spectra Medical's Device, Sodium Chloride Injection, 0.9%, USP, 10 mL Ampule is indicated only for use in flushing compatible intravenous tubing systems and in dwelling intravascular access devices. Spectra Medical's Sodium
2
p.3 of 3
Chloride Injection, 0.9%, USP, 10 mL Ampule is identical to the predicate device. The difference is that the Spectra medical product is in a 10 mL ampule whereas the predicate device is in a syringe.
PERFORMANCE CHARACTERISTIC SUMMARY 6.
There has been no change to the performance characteristics of the device system.
TECHNOLOGICAL CHARACTERISTICS 7.
There has been no change to the fundamental scientific technology.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA", which is arranged in a circular fashion around the left side of the logo.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 0 2009
Spectra Medical Devices, Incorporated C/o Mr. David Rosen Foley & Lardner LLP Washington Harbour 3000 K Street, NW. Suite 500 Washington, DC 20007
K082689 Re:
Trade/Device Name: Spectra Medical's Device, Sodium Chloride Injection, 0.9%, USP, 10ML Ampule Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: NGT Dated: March 2, 2009 Received: March 3, 2009
Dear Mr. Rosen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
4
Page 2 - Mr. Rosen
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Suite Y. Mchane Oms.
Ginette Y. Michaud, M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known)
Spectra Medical's Device, Sodium Chloride Injection, 0.9%, USP, 10mL Device Name: Ampule
Indications for Use:
The device is indicated only for use in flushing compatible intravenous tubing systems and in dwelling intravascular access devices. Not to be used for any other purposes.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
Prescription Use X (Per 21 CFR 801.109)
or
Over-the-Counter Use __
Shule F. Murphy, 10
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K 082689
WASH_5603719.1