(67 days)
No
The device description and intended use are for a standard syringe containing heparin, with no mention of AI/ML capabilities or related performance metrics.
No
The device is described as "only for use in flushing compatible intravenous administration sets and indwelling intravascular access devices." This function is maintenance/prevention of blockages, not directly treating a disease or condition.
No
The device is described as a syringe for flushing intravenous administration sets and indwelling intravascular access devices, which is a therapeutic or maintenance function, not a diagnostic one. No diagnostic capabilities or measurements are mentioned.
No
The device description explicitly states it is a "sterile, single use, standard piston syringe," which is a physical hardware device.
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 compatible intravenous administration sets and indwelling intravascular access devices." This is a direct therapeutic or procedural use within the body, not a diagnostic test performed on samples outside the body.
- Device Description: The device is a syringe containing heparin, which is a drug used for its anticoagulant properties. This aligns with the flushing purpose.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The proposed device is indicated only for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.
The Heparin Lock Flush Syringe, 10 and 100 units/ml is intended for flushing compatible intravenous administration sets and indwelling intravenous access devices.
Product codes
NGT
Device Description
The proposed device is a sterile, single use, standard piston syringe of various sizes and fill volumes containing either 10 or 100 USP Heparin units/ml.
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
Nonclinical Testing - Biocompatibility testing of the proposed device has demonstrated that it meets the requirements of guidelines presented in the 10993 ISO Standard, Part 1, with the FDA modified matrix presented in memorandum G95-1.
Key Metrics
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
EXHIBIT # 9
510(k) Summary
DEC 31 2001
In accordance with section 513(I) of the SMDA and as defined in 21 CFR Part 807.3 final rule dated December 14, 1994, this summary is submitted by:
The Kendall Company 15 Hampshire Street Mansfield, MA 02048 Date Prepared: November 26, 2001
-
- Contact Person
David A. Olson Director, Regulatory Affairs (508) 261-8530
- Contact Person
-
- Name of Medical Device
Catheter, Intravascular, Therapeutic, Short-Term Classification Name: Common or Usual Name: Monoject® PreFill Heparin Lock Flush Syringe
- Name of Medical Device
-
- Identification of Legally Marketed Device
The proposed Kendall Monoject® PreFill Flush Syringe is substantially equivalent in intended use, function and composition to Baxter Healthcare Corporations' Heparin Lock Flush Syringe, 510(k) No. K003245.
- Identification of Legally Marketed Device
-
- Device Description
The proposed device is a sterile, single use, standard piston syringe of various sizes and fill volumes containing either 10 or 100 USP Heparin units/ml.
- Device Description
-
- Device Intended Use
The proposed device is indicated only for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.
- Device Intended Use
-
- Product Comparison
1
The proposed device has the same technological characteristics as the predicate devices. Each consists of Monoject® plastic syringes containing Heparin Lock Flush Solution, USP.
7. Nonclinical Testing
Biocompatibility testing of the proposed device has demonstrated that it meets the requirements of guidelines presented in the 10993 ISO Standard, Part 1, with the FDA modified matrix presented in memorandum G95-1.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 31 2001
Mr. David A. Olson Director, Regulatory Affairs Tyco Healthcare Kendall Division 15 Hampshire Street Mansfield, Massachusetts 02048
Re: K013556
Trade/Device Name: Monojet Pre-Fill Heparin Lock Flush Syringe Regulation Number: 880.5200 Regulation Name: Catheter, Intravascular, Therapeutic, Short-Term Regulatory Class: II Product Code: NGT Dated: October 24, 2001 Received: October 25, 2001
Dear Mr. Olson:
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.
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
3
Page 2 - Mr. Olson
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 Of K Part 6077; lacemig (21 CFR Part 820); and if applicable, the electronic for an and quinny of eventions (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 promated predicated 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 31 31 594-4618. Additionally, for questions on the promotion and advertising of Compliance at (301) 594-4639 of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Other general international and Consumer 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,
Lillatoust
Timoth Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K 013550
KO13556 510(k) Number (if known):
(ii known):
Monoject Pre Fill Heparin Lock Flush Syringe, 10 and 100 units/m Device Name:_
Indications For Use:
The Heparin Lock Flush Syringe, 10 and 100 units/ml is intended for The ricpanni Lock Pract: Syints, 2001 administration sets and indwelling intravenous access devices.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | (Per 21 CFR 801.109) |
|---|---|
| ------------------ | --------------------------------- |
OR
| Over-The-Counter Use | (Optional Format 1-2-96) |
|---|---|
| ---------------------- | ------------------------------------- |
Vick Hibbard for Pat Cricenti
'Division Sign-Off) Envision of Dental, Infection Control, and General Hospital Devices · Norober KO13556