(73 days)
No
The description details a mechanical device for blood administration and makes no mention of AI or ML.
No.
This device is for the administration of blood/blood products, not for treating a disease or condition itself.
No
The device is described as a blood administration set for delivering blood/blood products, not for diagnosing any medical conditions.
No
The device description explicitly states it is a "single use, disposable, blood administration set with pressure pump and blood filter," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "deliver blood/blood products rapidly through use of the pressure pump and/or gravity flow." This describes a device used for the administration of a substance into the body, not for testing or analyzing a sample in vitro (outside the body).
- Device Description: The description reinforces this by detailing a "gravity blood set with a blood filter and hand pressure pump" for delivering blood.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely for the physical delivery of blood.
N/A
Intended Use / Indications for Use
The Blood Hand Pump Set will be used for patients that require blood. The set can be used by gravity flow or with hand pump compressions, depending on how quickly blood delivery is needed. It is intended for use by healthcare professionals (including nurses, doctors, emergency technicians, etc.) in clinical environments. The flow rate for hand pump compression administration may be as much as twice that of gravity flow.
A single use, disposable, blood administration set with pressure pump and blood filter used to deliver blood/blood products rapidly through use of the pressure pump and/or gravity flow.
Product codes
BRZ
Device Description
The Blood Hand Pump Administration Set is a single use, disposable, gravity blood set with a blood filter and hand pressure pump. The addition of the hand pressure pump provides the capability for delivering blood/blood products more rapidly by compressing the pump by hand. Blood sets with hand pressure pumps are typically used by healthcare professionals in clinical settings, including emergency rooms, intensive care units, operating rooms, surgery centers, trauma centers, and pre-hospital transport. Using a hand pump set increases the flow rate and helps ensure timely delivery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals (including nurses, doctors, emergency technicians, etc.) in clinical environments.
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)
The performance data indicate that the Cardinal Health, Alaris Products Blood Hand Pump Set meets specified requirements and is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
KD50115
APR - 1 2005 SUMMARY OF SAFETY AND EFFECTIVENESS Cardinal Health, Alaris Products Blood Hand Pump Set
SUBMITTER INFORMATION
| A. | Company Name: | Cardinal Health, Alaris® Products |
|---|---|---|
| B. | Company Address: | 10221 Wateridge Circle |
| San Diego, CA 92121-2733 | ||
| C. | Company Phone: | |
| Company Fax: | (858) 458-7830 | |
| (858) 458-6114 | ||
| D. | Contact Person: | Stacy L. Lewis |
| Sr. Regulatory Affairs Specialist | ||
| Cardinal Health, Alaris Products | ||
| E. | Date Summary Prepared: | March 16, 2005 |
DEVICE IDENTIFICATION
| A. | Generic Device Name: | Blood Administration Set |
|---|---|---|
| B. | Trade/Proprietary Name: | Blood Hand Pump Set |
| C. | Classification: | Class II |
| D. | Product Code: | BRZ, Blood Transfusion Set |
DEVICE DESCRIPTION
The Blood Hand Pump Administration Set is a single use, disposable, gravity blood set with a blood filter and hand pressure pump. The addition of the hand pressure pump provides the capability for delivering blood/blood products more rapidly by compressing the pump by hand. Blood sets with hand pressure pumps are typically used by healthcare professionals in clinical settings, including emergency rooms, intensive care units, operating rooms, surgery centers, trauma centers, and pre-hospital transport. Using a hand pump set increases the flow rate and helps ensure timely delivery.
1
SUMMARY OF SAFETY AND EFFECTIVENESS Cardinal Health, Alaris Products Blood Hand Pump Set Page 2 of 2
SUBSTANTIAL EQUIVALENCE
The Cardinal Health, Alaris Products Blood Hand Pump Administration Set is of comparable type and is substantially equivalent to the following predicate devices:
| Predicate Device | Manufacturer | 510(k) No. | Date Cleared |
|---|---|---|---|
| ALARIS Blood | |||
| Administration Set | Cardinal Health, Alaris | ||
| Products | K882302 | 7/12/1988 | |
| Baxter Fenwal Y-Type | |||
| Blood/Solution Set | Baxter Corporation | K881321 | 6/16/1998 |
INTENDED USE
The Blood Hand Pump Set will be used for patients that require blood. The set can be used by gravity flow or with hand pump compressions, depending on how quickly blood delivery is needed. It is intended for use by healthcare professionals (including nurses, doctors, emergency technicians, etc.) in clinical environments. The flow rate for hand pump compression administration may be as much as twice that of gravity flow.
TECHNOLOGICAL CHARACTERISTICS
A comparison of the technological characteristics of the Cardinal Health, Alaris Products Blood Hand Pump Set and the predicate devices has been performed. The results of this comparison demonstrate that the Blood Hand Pump Set is equivalent to the marketed predicate devices in technological characteristics.
PERFORMANCE DATA
The performance data indicate that the Cardinal Health, Alaris Products Blood Hand Pump Set meets specified requirements and is substantially equivalent to the predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized design featuring three curved lines that resemble an abstract representation of a human form or a symbol related to health and well-being.
Public Health Service
APR - 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Stacy L. Lewis Senior Regulatory Affairs Specialist Cardinal Health, Alaris Products 10221 Wateridge Circle San Diego, California 92121-2772
Re: K050115
Trade/Device Name: Blood Hand Pump Administration Set Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: BRZ Dated: January 17, 2005 Received: January 18, 2005
Dear Ms. Lewis:
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 (1 will) in the 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.
3
Page 2 - Ms. Lewis
Please be advised that FDA's issuance of a substantial equivalence determination does not I lease be advisor and a determination that your device complies with other requirements mount that I Dr mas and regulations administered by other Federal agencies. or the recor any a vary a vat's requirements, including, but not limited to: registration r od into comply with and 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CF Partis of 1, 2017, 1977, 1991, 1991, 1991, 1991, 1997, 1991, 1991, 1991, 11 requirements as bet form in one of 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) This letter wifi une in J . 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), rr you donto 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 maj oveans 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/industry/support/index.html.
Sincerely vours,
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
4
INDICATIONS FOR USE
| 510(k) Number: | K050115 | (To Be Assigned By FDA) |
|---|---|---|
| Device Trade Name: | Blood Hand Pump Administration Set |
Indications For Use:
A single use, disposable, blood administration set with pressure pump and blood filter used to deliver blood/blood products rapidly through use of the pressure pump and/or gravity flow.
Prescription Use _________X
(Per 21 CFR 801.109)
Over-The-Counter Use
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cim
200
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