(70 days)
Indicated as a single use, sterile device for use in I.V. therapy when an extended fluid path is required for administration. Environment of use: Hospital, Emergency Medical Services settings, wherever I.V. fluid administration may be indicated.
The GVS Speedflow I.V. Administration Set with Easydrop Flow Regulator consists of a tubing set with a 0.2um or a 1.2um filter, various connectors and accessories and an Easydrop flow regulator and is used as a fluid pathway for I.V. administration. A choice can be made on the volume of fluid by easily adjusting the drops/cc setting on the Easydrop Flow Regulator. GVS will offer custom sets to meet customer requirements and specifications.
The provided text describes the acceptance criteria and the studies conducted for the GVS Speedflow I.V. Set with Easydrop Flow Regulator.
Here's the information broken down by your requested categories:
1. Table of Acceptance Criteria and the Reported Device Performance
| Identified Risk | Mitigation Measure | Acceptance Criteria / Test Conducted | Reported Device Performance |
|---|---|---|---|
| Device Malfunction | Bench Testing | Leak testing on filter and sets. Joint strength testing. Flowrate testing (drops/minute). Filter Integrity testing. | Implied: The studies were performed to validate critical parameters required to reduce risk. The summary states that "The intended use, materials, and test results show that the GVS Speedflow I.V. Set with Easydrop Flow Regulator is substantially equivalent to predicate devices," implying successful performance in these bench tests. No specific numerical results are provided in this summary document. |
| Adverse Tissue Reaction | Biocompatibility | Per ISO 10993-10 (Sensitization), ISO 10993-11 (Acute Systemic Injection), ISO 10993-3 (Haemocompatibility), ISO 10993-5 (Cytotoxicity MEM Elution), ISO 10993-10 (Intracutaneous Injection). | Implied: The tests were conducted according to these ISO standards. The summary implies successful performance as part of the overall substantial equivalence claim. No specific numerical results are provided in this summary document. |
| Infection | Sterilization | Sterility Testing (according to ISO 11137). Shelf Life Testing (according to EN 868-5). Pyrogen Testing (LAL test method). Bacterial Retention Testing. | Sterility: Validated to a maximum dose of 40 kGy's, with a sterility assurance level of 10-6. Shelf Life: A validation resulted in a 5-year shelf life. Pyrogen Testing: Sets were tested by the LAL test method and were found to be ≤0.25 EU/ml. Bacterial Retention (0.2um filter): Found to remove >99.9% of Brevundimonas diminuta. Bacterial Retention (1.2µm filter): Found to remove ≥99.9% of Candida Albicans. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the exact sample sizes used for each individual test. It mentions "Bench Testing" and "Biocompatibility testing" without enumerating the number of units or animals tested.
The data provenance is not explicitly stated in terms of country of origin of the data or whether it was retrospective or prospective. However, GVS S.p.A. is located in Italy (BOLOGNA), suggesting the testing was likely conducted in Europe or by contractors approved by GVS.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This type of information is not applicable to this device. The tests performed are primarily laboratory (bench) tests and biological assays, not studies requiring expert interpretation of medical images or patient outcomes. The "ground truth" for these tests is established by objective measurements against established international standards (ISO, EN) and industry recommendations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable to this device. Adjudication methods like 2+1 or 3+1 typically refer to consensus-building among multiple human reviewers for subjective assessments (e.g., medical image interpretation). The tests for this I.V. set are objective, laboratory-based measurements.
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 is not applicable to this device. This device is an I.V. administration set and does not involve AI or human readers for diagnostic interpretation. Therefore, no MRMC comparative effectiveness study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable to this device. This device is an I.V. administration set, which is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the tests performed on this device is based on:
- Established International Standards: ISO 14971 (Risk Analysis), ISO 10993 series (Biocompatibility), ISO 11137 (Sterilization), EN 868-5 (Shelf Life).
- Objective Laboratory Measurements: Leakage, joint strength, flowrate (drops/minute), filter integrity, sterility assurance level, pyrogen limits (EU/ml), bacterial removal efficiency (percentage).
- Industry Recommendations: For bacterial retention testing.
8. The sample size for the training set
This is not applicable to this device as it is a physical medical device, not an AI or machine learning algorithm that requires a "training set."
9. How the ground truth for the training set was established
This is not applicable to this device for the same reason as above.
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5. 510(k) Summary
JUN 3 0 2006
Summary Prepared: 28 Dec 2005 Common Name: Speedflow I.V. Set with Easydrop Flow Regulator Classification Name: Intravascular Administration Sets Product Code: FPA Panel: General Hospital and Personal Use Device Classification: II
Substantially Equivalent to: B. Braun; Filterflow Filtered Extension Sets Amsino: I.V. Administration Sets Leventon; I.V. Extension Sets with I.V. Flow Regulators
Description: The GVS Speedflow I.V. Administration Set with Easydrop Flow Regulator consists of a tubing set with a 0.2um or a 1.2um filter, various connectors and accessories and an Easydrop flow regulator and is used as a fluid pathway for I.V. administration. A choice can be made on the volume of fluid by easily adjusting the drops/cc setting on the Easydrop Flow Regulator. GVS will offer custom sets to meet customer requirements and specifications.
Indicated as a single use, sterile device for use in gravity fed I.V. therapy when an Intended Use: extended fluid path is required for administration.
Risk Analysis Method-1SO 14971 was used for the Risk Analysis. The specific risks associated with this device were:
| Identified Risk | Mitigation Measure |
|---|---|
| Device Malfunction | Bench Testing |
| Adverse Tissue Reaction | Biocompatibility |
| Infection | Sterilization |
| Improper Use | Labeling |
Device Characteristics: In order to validate critical parameters of the product required to reduce risk, the following were performed:
Device Malfunction = Bench tests Leak testing on filter and sets. Joint strength testing, Flowrate testing (drops/minute), Filter Integrity testing
GVS S.p.A. Via Roma, 50 40069 - Zola Predosa (BOLOGNA) - Italia
Tel. +39 051 6176311 Fax +39 051 6176200 e-mail: gys@gvs.it www.gvs.com
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Image /page/1/Picture/16 description: The image shows a monogram consisting of the letters G, V, and S. The letters are stylized and intertwined, with the 'V' in the center and the 'G' and 'S' on either side. Below the monogram, there is a small droplet shape.
- 510(k) Summary - continued
Adverse Tissue Reaction = Biocompatibility
ISO 10993-10. Sensitization, ISO 10993-11, Acute Systemic Injection, ISO 10993-3, Haemocompatibility; ISO 10993-5, Cytotoxicity MEM Elution; ISO 10993-10, Intracutaneous Injection
Infection = Sterilization
Sterility Testing: According to ISO 11137, the product has been validated to a maximum dose of 40 kGy's, with a sterility assurance level of 10-6.
Shelf Life Testing: A validation was performed according to EN 868-5 resulting in a 5 year shelf life.
Pyrogen Testing: Sets were tested by the LAL test method and were found to be ≤0.25 EU/ml.
Bacterial Retention Testing: Per industry recommendations,
The 0.2um was tested and found to remove >99.9% of the challenged organism, Brevundimonas diminuta.
The 1.2 µm was tested and found to remove ≥99.9% of the challenged organism, Candida Albicans.
Summary: The intended use, materials, and test results show that the GVS Speedflow I.V. Set with Easydrop Flow Regulator is substantially equivalent to predicate devices.
Tel. +39 051 6176311 Fax +39 051 6176200 e-mail: gys@gvs.it www.gvs.com
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes forming its body and wing. The seal is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement.
JUN 3 0 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
GVS SPA C/O Ms. Dawn I. Moore Consultant 20171 Bowens Road Manchester, Michigan 48158-9600
Re: K061115
Trade/Device Name: I.V. Administration Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: April 19, 2006 Received: April 21, 2006
Dear Ms. Moore:
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.
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Page 2 - Ms. Moore
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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,
unmi UDIT
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
| 510(k) Number (if known): | K061115 |
|---|---|
| Device Name: | I.V. Administration Sets |
| Indications For Use: | |
| Indicated as a single use, sterile device for use in I.V. therapy when an extended fluid path is required for administration. Environment of use: Hospital, Emergency Medical Services settings, wherever I.V. fluid administration may be indicated. | |
| Prescription Use | X |
| 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 (ODE)
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11:1mber______________________________________________________________________________________________________________________________________________________________________
§ 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.