(589 days)
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Not Found
No
The description focuses on a mechanical safety feature (needle retraction) and does not mention any computational or data-driven processes indicative of AI/ML.
No
The "Intended Use / Indications for Use" section explicitly states, "The device is not used for a diagnostic or treatment purpose." While it can be used for intravenous fluid administration, which might be part of a therapy, the device itself is not classified as a therapeutic device.
No
The "Intended Use / Indications for Use" section explicitly states, "The device is not used for a diagnostic or treatment purpose." The device is primarily for blood collection and short-term fluid administration.
No
The device description clearly indicates a physical blood collection set with a needle and a push-button retraction mechanism, which are hardware components.
Based on the provided information, the Ultraflo-R Push Button Blood Collection Set is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The primary intended use is for venipuncture to obtain blood specimens and for short-term intravenous fluid administration. While blood is collected, the device itself is for the collection and administration, not for performing a diagnostic test on the blood specimen.
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The device is not used for a diagnostic or treatment purpose." This directly contradicts the definition of an IVD, which is used for diagnostic purposes.
IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device is used in vivo (within the body) for collection and administration.
N/A
Intended Use / Indications for Use
The Ultraflo-R Push Button Blood Collection Set is a sterile, single-use, winged blood collection set intended for vempuncture to obtain blood specimens from patients. The device is connected to a syringe or evacuated blood collection tube for collection of the specimen.
The Ultraflo-R Push Button Blood Collection Set is also indicated for short-term (up to 2 hours) intravenous administration of fluids and may be used for patient populations over 2500 grams with consideration given to patient size, appropriateness for the solution being infused and duration of therapy.
After completion of the blood draw or infusion, the recommended use of the device is to depress the button on the top of the device to activate needle retraction into the device prior to removal from the venipuncture site. This is a one-handed activation of the safety feature. The retraction of the intravenous (IV) end of the needle aids in the prevention of accidental needle-stick injury.
The device is not used for a diagnostic or treatment purpose.
Product codes
JKA, FPA
Device Description
The Ultraflo-R Push Button Blood Collection Set is a sterile, single-use, winged blood collection set. It is designed to be connected to a syringe or evacuated blood collection tube for obtaining blood specimens. It also includes a push-button mechanism for needle retraction to prevent accidental needle-stick injury after use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Venipuncture site
Indicated Patient Age Range
Patient populations over 2500 grams
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1675 Blood specimen collection device.
(a)
Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below.
October 30, 2023
Innovative Medical Technologies, Inc. Brad Brown President 14315 C Circle Omaha, Nebraska 68144
Re: K220458
Trade/Device Name: UltraFlo-R Push Button Blood Collection Set Regulation Number: 21 CFR 862.1675 Regulation Name: Blood specimen collection device Regulatory Class: Class II Product Code: JKA, FPA
Dear Brad Brown:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated September 29, 2023. Specifically, FDA is updating this SE Letter to include the signatory name as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact David Wolloscheck, OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices, 301-796-1480, David.Wolloscheck(@fda.hhs.gov.
Sincerely,
Porsche Bennett
Porsche Bennett For David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Image /page/1/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the U.S. Food and Drug Administration. The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white. Underneath the square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
September 29, 2023
Innovative Medical Technologies, Inc. Brad Brown President 14315 C Circle Omaha, Nebraska 68144
Re: K220458
Trade/Device Name: UltraFlo-R Push Button Blood Collection Set Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: Class II Product Code: JKA, FPA Dated: August 7, 2023 Received: August 30, 2023
Dear Brad Brown:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrb/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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Sincerely,
Porsane Bennett
For David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K220458
Device Name UltraFlo-R Push Button Blood Collection Set
Indications for Use (Describe)
The Ultraflo-R Push Button Blood Collection Set is a sterile, single-use, winged blood collection set intended for vempuncture to obtain blood specimens from patients. The device is connected to a syringe or evacuated blood collection tube for collection of the specimen.
The Ultraflo-R Push Button Blood Collection Set is also indicated for short-term (up to 2 hours) intravenous administration of fluids and may be used for patient populations over 2500 grams with consideration given to patient size, appropriateness for the solution being infused and duration of therapy.
After completion of the blood draw or infusion, the recommended use of the device is to depress the button on the top of the device to activate needle retraction into the device prior to removal from the venipuncture site. This is a one-handed activation of the safety feature. The retraction of the intravenous (IV) end of the needle aids in the prevention of accidental needle-stick injury.
The device is not used for a diagnostic or treatment purpose.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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