(236 days)
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.
The product is Single Use Sterile Infusion Set for Medical Use. The infusion set consists of the components as illustrated in figure given below.
The provided text is a Premarket Notification [510(k)] Summary for an "I.V. Administration Set" by Angiplast Pvt. Ltd. This document primarily focuses on establishing "substantial equivalence" to existing legally marketed devices, rather than presenting a detailed study proving the device meets specific acceptance criteria with performance metrics.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth establishment, and MRMC studies are not present in the provided text. The document refers to compliance with ISO standards and comparisons to predicate devices as the basis for equivalence.
Here's an attempt to answer the questions based only on the provided information, highlighting what is not available:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with specific numerical targets or a detailed report of the device's performance against such criteria. Instead, it states:
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Compliance with ISO 8536-4 | "Our brand comply with the requirements of ISO 8536-4 in all critical requirements." |
| Substantial Equivalence to Predicate Devices | "From the comparison it is observed that our product is found to be substantially equivalent to Two similar American Products." |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The text does not describe a "test set" and thus, no sample size or data provenance (country of origin, retrospective/prospective) for such a set. The "comparison" mentioned refers to technical characteristics against predicate devices, not a clinical or performance test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. There is no mention of "experts" establishing "ground truth" for a test set.
4. Adjudication Method for the Test Set
This information is not provided in the document. As no "test set" is described, there is no mention of an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If So, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not provided in the document. The device is an "I.V. Administration Set," a medical hardware device, not an AI or software device that would involve human readers or AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided in the document. The device is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
This information is not provided in the document beyond the implication that adherence to ISO 8536-4 and comparison to predicate devices serves as the "truth" for establishing substantial equivalence. This is based on technical characteristics and regulatory compliance rather than expert consensus, pathology, or outcomes data from a specific study.
8. The Sample Size for the Training Set
This information is not provided in the document. There is no mention of a "training set" as this is not an AI/ML device.
9. How the Ground Truth for the Training Set was Established
This information is not provided in the document. As no "training set" is mentioned, no ground truth establishment method for it is described.
Summary of the Study (as described in the document):
The document describes a Premarket Notification [510(k)] Summary intending to demonstrate substantial equivalence of the Angiplast I.V. Administration Set to two legally marketed predicate devices:
- PRIMARY I.V. SET, Convertible Pin, 100 Inch with Backcheck Valve and 2 CLAVE® ports Piggyback MICRODRIP® with OPTION-LOK® (Trade Name: LifeShield®) manufactured by Abbott Laboratories.
- Continu-Flo® Solution Set (Trade Name: Interlink® System) manufactured by Baxter Healthcare Corporation.
The "study" or justification for equivalence presented relies on:
- Comparison of Technical Characteristics: The document states, "Summary of comparative technical characteristics... From the comparison it is observed that our product is found to be substantially equivalent to Two similar American Products." However, the actual comparative table of detailed characteristics is not provided in a readable format in the extracted text (it appears as scanned text with significant OCR errors).
- Compliance with International Standards: The document explicitly states, "The two American brands as well as our brand comply with the requirements of ISO 8536-4 in all critical requirements." ISO 8536-4 is the standard for "Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed." This compliance suggests that the device meets established safety and performance benchmarks for IV administration sets.
The FDA's response (K012189 dated March 5, 2002) confirms that they "reviewed your Section 510(k) premarket notification of intent to market the device... [and] have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This FDA determination is the "proof" that the device meets the implied acceptance criteria for market entry under the 510(k) pathway, which is substantial equivalence to a predicate device.
{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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|---|---|---|---|
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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 |
| with the first to the first and the charges and any and any and any and a | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | .--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | and and season and the direction of the climit of the climit of the climit of the climit of the climit of the climit of the climit of the climit of the climit of the client o-------------------Concession Colline Collins of------------------------------------------------------------------------------------------------------------------------.------- |
|---|---|---|---|
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| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------1 | .------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------. In come a second a some a more a------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
{2}------------------------------------------------
| 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 ofManufacturer | : Baxter Healtchcare CorporationDeerfield, 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.: 1Date: January 1, 2001 | |||
|---|---|---|---|---|
| Device Master File - 510(k) | Revision No.: 2Date: 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 usingDEHPplasticizer | |
| 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 infuseparenteral solution | HDPE |
| 10 Protective cap of the malefitting | To protect end of male fitting and to maintainsterility 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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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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§ 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.