(236 days)
Not Found
No
The summary describes a standard infusion set with no mention of AI/ML components or functionalities.
No.
The primary stated use is for administering fluids/medication, which is a delivery mechanism, not a therapeutic action itself.
No
The device is described as an "Infusion Set for Medical Use" intended to "administer parenteral fluids / medication." This is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it is an "Infusion Set" and lists physical components, indicating it is a 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 to "administer parenteral fluids / medication into the patient's intravascular system." This describes a device used for direct patient treatment and delivery of substances into the body.
- Device Description: The description confirms it's a "Single Use Sterile Infusion Set for Medical Use," which is consistent with a device used for administering fluids intravenously.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body, while this device is used to introduce substances into the body.
N/A
Intended Use / Indications for Use
To administer parenteral fluids / medication into the patient's intravascular system.
The sterile I.V. Administration Set is indicated for use to administrater parenteral fluids medication into the paticits vascular system.
Product codes (comma separated list FDA assigned to the subject device)
FPA
Device Description
The product is Single Use Sterile Infusion Set for Medical Use. The infusion set consists of the components as illustrated in figure given below: a protective cap, a closure-piercing device, an air vent filter assembly, a drip chamber, a fluid filter, tubing, a flow regulator, an injection site, a male fitting (Adaptor), and a protective cap of the male fitting.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intravascular system
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.
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
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
0
| Angiplast Pvt. Ltd., Ahmedabad, India | Issue No.: 1 |
|---|---|
| Device Master File - 510(k) | Date: January 1, 2001 |
| L.V. ADMINISTRATION SET | Revision No.: 2 |
| Date: January 1, 2002 |
K012/89
5 2002 mar
15.0 PREMARKET NOTIFICATION [ 510(K) ] SUMMARY
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1
| Angiplast Pvt. Ltd., Ahmedabad, India | Issue No.: 1 |
|---|---|
| Date: January 1, 2001 | |
| Device Master File - 510(k) | Revision No.: 2 |
| Date: January 1, 2002 | |
| I.V. ADMINISTRATION SET |
-
Name, Address and Phone numbers of Manufacturer 15.1
5 2002 MAR -
Name of Submitter .
Image /page/1/Figure/4 description: The image shows a signature block. The name "Mr. Ashit B. Shah" is printed on the left side of the block, with the title "Director" printed below it. On the right side of the block, the word "Signature" is printed below a signature line, and a signature is written above the line. -
Registered address and address of manufacturing and sterilization plant .
| ANGIPLAST PRIVATE LIMITED | |
|---|---|
| 4803, Phase-IV, G.I.D.C. Estate, | |
| Vatva, Ahmedabad 382 445 | |
| India | |
| Phone No.: | +91 79 584 0661 / 584 1967 |
| Fax No.: | +91 79 584 1009 |
| E-mail: | medical.appl@gems.vsnl.net.in |
- Date: 18-6-2001 ●
Details of legally marketed device to which we claim equivalence 15.2
| 1. Name & Description | PRIMARY I.V. SET, Convertible Pin, 100 Inch with Backcheck Valve and 2 CLAVE® ports Piggyback MICRODRIP® with OPTION-LOK® |
|---|---|
| Trade Name | LifeShield® |
| Name & Address of Manufacturer | Abbott Laboratories, North Chicago, IL 60064, USA |
|
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| Angiplast Pvt. Ltd., Ahmedabad, India | Issue No.: 1 |
|---|---|
| Device Master File - 510(k) | Revision No.: 2 |
| I.V. ADMINISTRATION SET | Date: January 1, 200 |
| Date: January 1, 200 |
| 2. | Name & Description | : Continu-Flo® Solution Set |
|---|---|---|
| Trade Name | : Interlink® System | |
| Name & Address of | ||
| Manufacturer | : Baxter Healtchcare Corporation | |
| Deerfield, IL 60015 USA |
Description of the Device 15:3
- The product is Single Use Sterile Infusion Set for Medical Use. .
The infusion set consists of the components as illustrated in figure given below.
Image /page/2/Figure/5 description: This image shows a diagram of an intravenous (IV) infusion set and a table describing the components. The diagram shows the different parts of the IV set, labeled with numbers 1 through 10. The table lists four components: a protective cap, a closure-piercing device, an air vent filter assembly, and a drip chamber. The table also includes the intended use and material of each component, such as polypropylene (PP), acrylonitrile butadiene styrene (ABS), and polyvinyl chloride (PVC).
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3
| Angiplast Pvt. Ltd., Ahmedabad, India | | | Issue No.: 1
Date: January 1, 2001 | |
|---------------------------------------|----------------|-----------------------------------------------------------------------------------|------------------------------------------|--|
| Device Master File - 510(k) | | | Revision No.: 2
Date: January 1, 2002 | |
| I.V. ADMINISTRATION SET | | | | |
| 5 | Fluid filter | To filter parenteral solution | HDPE | |
| 6 | Tubing | To transfer the parenteral solution from bottle /
plastic container to patient | PVC using
DEHP
plasticizer | |
| 7 | Flow regulator | To control flow of infusion of parenteral solution | PP, HDPE | |
| 7 Flow regulator | To control flow of infusion of parenteral solution | PP, HDP |
|---|---|---|
| 8 Injection site | To administer extra medicament during infusion | Latex |
| 9 Male fitting (Adaptor) | To connect with female fitting used to infuse | |
| parenteral solution | HDPE | |
| 10 Protective cap of the male | ||
| fitting | To protect end of male fitting and to maintain | |
| sterility of interior of infusion set | LDPE |
Intended use of the Medical Device: 15:4
8 9
10
To administer parenteral fluids / medication into the patient's intravascular system.
- Summary of the technical characteristics of our device compared to legally marketed ાર રિંદર devices (two American brands)
- Summary of comparative technical characteristics 1.
From the comparison it is observed that our product is found to be substantially equivalent to Two similar American Products. The two American brands as well as our brand comply with the requirements of ISO 8536-4 in all critical requirements.
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4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three wing-like shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 5 2002
Mr. Ashit B. Shah Director Angiplast Private Limited 4803, Phase IV, G. I. D. C., Vatva Ahmedabad, INDIA
Re: K012189
Trade/Device Name: Angeltouch Vented IV Adminstration Set Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Il Product Code: FPA Dated: January 11, 2002 Received: January 15, 2002
Dear Mr. Shah:
We have reviewed your Section 510(k) premarket notification of intent to market the device We nuro roviewed your becamined 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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendinone, or to act roometic Act (Act) that do not require approval of a premarket the rederal I vou, Drag, and Ocamons , therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls providents of a 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 (1 wr t), it may over in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear or roundsh further announcements concerning your device in the Federal Register.
5
Page 2 - Mr. Shah
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. or the For of 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 (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.
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618 . 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and alle Net 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,
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
| Angiplast Pvt. Ltd.; Ahmedabad, India | Issue No.: 1 |
|---|---|
| Device Master File-510(k) | Date: January 1, 2001 |
| I.V. ADMINISTRATION SET | Revision No.: 3 |
| Date: February 20, 2002 |
12.0 STATEMENT OF INDICATIONS FOR USE
To administer parenticral fluids / medication into the patient's vascular system.
:: ….
The sterile I.V. Administration Set is indicated for use to administrater parenteral fluids medication into the paticits vascular system.
Patricio Cucente
(Division Sign-Off) (Division Sign-On)
Division of Dental, Infection Control, Division of a Hospital Devices 510(k) Number -----------10
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