(8 days)
- The I-Flow Elastomeric Pump is intended for continuous and/or intermittent infusion of medications for general infusion use, including antibiotic delivery, chemotheraly and pain management. Routes of administration include the following: intravenous, intra-arterial, subcutaneous, intramuscular and epidural.
- The I-Flow Elastomeric Pump is also intended for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural or percutaneous.
The I-Flow Elastomeric Pump consists of an elastomeric pressure source with an integrated administration line. This special 510(k) proposes a change from latex to polyisoprene for the outer bladder. The outer bladder is not in contact with the fluid path and thus does not require biocompatibility. The inner bladder will remain the same and thus drug compatibility will not be affected.
The provided document is a 510(k) submission for a change in material for the I-Flow Elastomeric Pump, specifically switching the outer bladder from latex to polyisoprene. This is a "Special 510(k)," which indicates a modification to an existing device where the design control activities are sufficient to demonstrate substantial equivalence.
Given the nature of a Special 510(k) for a material change that does not contact the fluid path and where drug compatibility is not affected, the submission focuses on demonstrating that the new material (polyisoprene) has similar properties to the existing material (latex) and that the device still performs as intended. Therefore, the "acceptance criteria" and "study" are not presented as a traditional performance study with accuracy metrics, but rather as a demonstration of material equivalence and continued device functionality.
Here's the breakdown based on the provided information:
1. A table of acceptance criteria and the reported device performance
The document doesn't present explicit numerical acceptance criteria and a performance table in the typical sense of accuracy or precision. Instead, the acceptance criterion is implicitly that the device with the new material remains substantially equivalent to the predicate device. The performance is summarized by stating the two materials have "similar properties" and that the material change does not impact drug compatibility.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device with latex bladder | The new polyisoprene bladder and the existing latex bladder are "two different types of elastomers with similar properties." The outer bladder is not in contact with the fluid path, and the inner bladder remains the same, so "drug compatibility will not be affected." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not provide information on a specific test set sample size or data provenance for a performance study. As this is a material change for a non-fluid-contact component, the "study" appears to be more focused on material characterization and engineering assessment rather than a clinical or performance testing study with
patient samples.
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 information is not applicable and not provided. The context is a material change for a medical device's component. There's no "ground truth" to be established by experts in the sense of diagnostic accuracy or clinical outcomes. The assessment is likely performed by engineers and material scientists from the manufacturer.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable and not provided. There's no mention of an adjudication process as there is no "test set" in the context of diagnostic interpretation.
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 applicable and not provided. The device is an elastomeric infusion pump, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. The device is an elastomeric infusion pump, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not applicable and not provided. There is no "ground truth" in the clinical sense mentioned, as the study pertains to material properties and substantial equivalence, not clinical diagnosis or outcomes.
8. The sample size for the training set
This information is not applicable and not provided. There is no mention of a "training set" as this is not a machine learning or AI device.
9. How the ground truth for the training set was established
This information is not applicable and not provided. As there's no training set, there's no ground truth establishment for it.
In summary, this 510(k) submission is for a material change that is considered minor because it does not affect device performance or patient contact. The "study" referenced is the demonstration that the new material is functionally equivalent to the old material and does not impact critical device features like drug compatibility. The typical metrics and study designs for diagnostic devices or AI systems are not relevant here.
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MAR 2 6 2002
I-Flow Corporation
SPECIAL 510(K) - SUMMARY OF SAFETY AND EFFECTIVENESS
March 15, 2002
Submitter:
| 20202 Windrow DriveLake Forest, CA 92630 | |
|---|---|
| Contact: | Shane NoehreManager, Regulatory AffairsI-Flow Corporation |
| Trade Name: | I-Flow Elastomeric Pump |
| Common Name: | Infusion Pump and Administration Set |
| Classification Name: | Pump, Infusion |
| Existing Device: | I-Flow Elastomeric Pump (K932740, K944692, K984502, K991513,K992072, and K020660 (pending)). |
| Device Description: | The I-Flow Elastomeric Pump consists of an elastomeric pressuresource with an integrated administration line. This special 510(k)proposes a change from latex to polyisoprene for the outer bladder.The outer bladder is not in contact with the fluid path and thus doesnot require biocompatibility. The inner bladder will remain the sameand thus drug compatibility will not be affected. |
| TechnologyComparison: | There is no change in technology. The latex and polyisoprene |
Conclusion: The I-Flow Elastomeric Pump with polyisoprene bladder is substantially equivalent to the existing I-Flow Elastomeric Pump with latex bladder.
bladder are two different types of elastomers with similar properties.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Image /page/1/Picture/12 description: The image shows a circular logo for the Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized caduceus with three intertwined snakes and a staff. The emblem is positioned to the right of the text, which is arranged in a circular pattern around the emblem. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
MAR 2 6 2002
Mr. Shane Noehre Manager, Regulatory Affairs I-Flow Corporation 20202 Windrow Drive Lake Forest, California 92630
Re: K020862
Trade/Device Name: I-Flow Elastomeric Pump Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MEB Dated: March 15, 2002 Received: March 18, 2002
Dear Mr. Noehre:
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.
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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 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 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,
Susan Quonor
PTimothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/3/Picture/0 description: The image shows the logo for I-Flow Corporation. The logo consists of the text "I-FLOW" in a bold, sans-serif font, with a small droplet icon above the "I". The text is enclosed in a rounded rectangle. Below the logo is the text "I-Flow Corporation" in a smaller font.
20202 Windrow Drive
Lake Forest, CA 92630
Tel: 800.448.3569 or 949.206.2700
Fax: 949.206.2600
www.i-flowcorp.com
| Ver/ 3 | - 4/24/96 |
|---|---|
| -------- | ----------- |
Applicant:
I-Flow Corporation
510(k) Number (if known):
Device Name:
I-Flow Elastomeric Pump
Indications For Use:
-
- The I-Flow Elastomeric Pump is intended for continuous and/or intermittent infusion of medications for general infusion use, including antibiotic delivery, chemotheraly and pain management. Routes of administration include the following: intravenous, intra-arterial, subcutaneous, intramuscular and epidural.
-
- The I-Flow Elastomeric Pump is also intended for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural or percutaneous.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Patacus Cuscetta
r: of Dental, Infer Theral Hospital I
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).