(219 days)
Not Found
No
The device description and intended use clearly indicate it is a sterile saline solution for flushing, with no mention of any computational or analytical capabilities.
No.
The device is indicated for flushing and dwelling, not for treating a disease or condition. It is a Sodium Chloride injection used to maintain the patency of intravenous tubing and access devices.
No
Explanation: The device is indicated for flushing and dwelling in intravenous tubing systems and access devices. It is a Sodium Chloride injection, an irrigant, and its intended use does not involve diagnosing medical conditions or diseases.
No
The device description clearly states it is "Sodium Chloride Injection, 0.9%, USP 5 mL, 10 mL Ampule," which is a physical drug 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 clearly stated as flushing intravenous tubing systems and dwelling intravascular access devices. This is a direct interaction with the patient's circulatory system and medical devices used for patient care, not the examination of specimens derived from the human body.
- Device Description: The device is Sodium Chloride Injection, 0.9%, USP. This is a sterile solution for injection, not a reagent, instrument, or system intended for use in the in vitro examination of specimens.
- Anatomical Site: The anatomical site is intravenous tubing systems and dwelling intravascular access devices, which are external to the body in terms of the device's direct action, but related to the patient's circulatory system. IVDs typically involve specimens taken from the body (blood, urine, tissue, etc.).
- Lack of IVD Characteristics: There is no mention of analyzing specimens, detecting substances in specimens, or providing information about a physiological state, health, disease, or congenital abnormality based on specimen analysis.
In summary, the device is a medical product used directly in patient care procedures related to intravenous access, not for laboratory testing of biological samples.
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 (comma separated list FDA assigned to the subject device)
NGT
Device Description
Spectra Medical's Device, Sodium Chloride Injection, 0.9%, USP 5 mL, 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): 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.
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
§ 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
p |
.. . .
510(k) Summary - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
JUL 29 2011
for
Spectra Medical's Device, Sodium Chloride Injection, 0.9%, USP 5 mL, 10 mL Ampule 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.
1. DATE PREPARED
December 20, 2010 -
2. SPONSOR INFORMATION
NAME, ADDRESS AND TELEPHONE/FACSIMILE NUMBER A.
Spectra Medical Devices, Inc. 260 F & H Fordham Rd. 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
3. DEVICE NAME
Proprietary Name:
Sodium Chloride Injection, 0.9%, USP 5 mL, 10 mL Ampule
.
103740
Common/Usual Name:
、ニュース - ミニー - ミニ - ミニ - ニー - - ニー - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Sodium Chloride Injection, 0.9%, USP 5 mL, 10 mL Ampule
Classification Names and numbers: Saline, Vascular Access Flush Class II, General Hospital, NGT.
4. DEVICE DESCRIPTION AND INTENDED USE
Spectra Medical's Device, Sodium Chloride Injection, 0.9%, USP
5 mL, 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.
ર. PREDICATE DEVICE
- a. K082689 - Sodium Chloride Injection, 0.9%, USP 10 Ml Ampule K023740 - Syrex Pre-filled Syringe with 0.9% Sodium Chloride
b. Substantial Equivalence Comparison
2
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Image /page/2/Picture/1 description: The image shows the text "K103740" in a handwritten style. The numbers are slightly uneven, and the overall appearance suggests it was written quickly. Below the number, there is a smaller subscript "p3".
. .---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Spectra Medical's device, Sodium Chloride Injection, 0.9%, USP 5 mL, 10 mL Ampule 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. Spectra Medical's Sodium Chloride Injection, 0.9%, USP is identical to the predicate device. The difference is that the Spectra Medical product is in 5 mL and 10 mL ampules whereas Spectra Medical's previous cleared product was in a 10 mL ampule and the Syrex predicate device is in a syringe.
6. PERFORMANCE CHARACTERISTIC SUMMARY
There has been no change to the performance characteristics of the device system.
7. TECHNOLOGICAL CHARACTERISTICS
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with outstretched wings, rendered in a simple, graphic style.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Spectra Medical Devices. Incorporated C/O Mr. David L. Rosen, B.S. Pharm., J.D. Foley & Lardner. LLP 3000 K Street, NW Washington, District of Columbia 20007
JUL 2 9 2011
Re: K103740
Trade/Device Name: Sterile Sodium Chloride 0.9% Flush, 5 mL and 10 mL Ampules Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: NGT Dated: June 9, 2011 Received: June 9, 2011
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Susan Runner
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Center for Devices and Radiological Health December 21, 2010 Page 12 of 12
510(k) Number (if known) K | 03 7 4 0
Device Name: Sterile Sodium Chloride 0.9% Flush, 5 mL and 10 mL Ampules
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.
Prescription Use X (Per 21 CFR 801.109)
or
Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
Elaine S. Marshall la&FC
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control and Dental Dovica
K103740