(82 days)
Blood Product Specialties Pedi-Syringe Filter™ is intended to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma and cryoprecipitate for pediatric and/or neonatal transfusion.
Tubing assembly with a 150 micron filter connected by tubing to a spike at one end and connected by tubing to a piston syringe at the other end. Between the filter and the spike there is a clamp.
The provided text is a 510(k) premarket notification for a medical device called the "Pedi-Syringe Filter™". The document discusses the device's intended use and FDA's substantial equivalence determination, but it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.
The 510(k) summary (page 1, section "Device Description") describes the device as a "Tubing assembly with a 150 micron filter connected by tubing to a spike at one end and connected by tubing to a piston syringe at the other end. Between the filter and the spike there is a clamp."
The "Intended Use" (page 1) states: "Intended to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets plasma and cryoprecipitate for pediatric and/or neonatal transfusion."
The FDA's letter (pages 2-4) confirms that the device is "substantially equivalent" to a legally marketed predicate device (Charter Medical Neonatal Syringe Set K000685). This substantial equivalence determination means that the FDA believes the new device is as safe and effective as the predicate device already on the market. However, a 510(k) submission primarily focuses on demonstrating substantial equivalence, and it does not typically require or present detailed performance acceptance criteria and a study report demonstrating the device meets those criteria in the same way a PMA (Premarket Approval) submission would.
Therefore, I cannot provide the requested information from the given text. The document does not contain:
- A table of acceptance criteria and reported device performance.
- Sample sizes for a test set or data provenance.
- Number of experts used or their qualifications for ground truth.
- Adjudication method for a test set.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study or effect sizes of human readers with/without AI.
- Information about a standalone algorithm performance study.
- The type of ground truth used (e.g., pathology, outcomes data).
- Sample size for a training set.
- How ground truth was established for a training set.
This document is a regulatory approval notice based on substantial equivalence, not a detailed performance study report.
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Blood Product Specialties LLC
Image /page/0/Picture/1 description: The image shows the text "K050805" and "March 29, 2005". The text appears to be handwritten, with the "K" and the numbers being in a cursive style. The date is written in a more standard font.
510(k) Notification Pedi-Śyringe Filter™
114
JUN 2 0 2005
Page 4
.
510(k) Summary
| Applicant:Address | Blood Product Specialties LLC65 Commerce WayHackensack, NJ 07601 |
|---|---|
| Contact Person: | Alan A. Waldman. Ph.D. |
| Address | Waldman Biomedical ConsultancyP.O. Box 575Oceanside, NY 11572 |
| Telephone | (516) 763-1158 |
| FAXEmail | (516) 536-7628draaw@aol.com |
| Submission Correspondent: | Jane Campbell |
| Telephone | (845) 469-4289 |
| FAX | (845) 469-4212 |
| jdca@optonline.net | |
| Device Information: | |
| Trade Name: | These devices will be marketed under the trade namePedi-Syringe Filter™ in either 30 mL or 60 mL size |
| Common/Usual Name: | Fluid reservoir and delivery system |
| Classification Name: | The classification name which most closely describesthese devices is "Set. Blood Transfusion" |
| Establishment | |
| Registration Number: | 2248588 |
| Class: | II |
| Panel: | 80 |
| Product code: | BRZ |
| Predicate Device: | Charter Medical Neonatal Syringe Set (K000685) |
| Device Description: | Tubing assembly with a 150 micron filter connected bytubing to a spike at one end and connected by tubing to a pistonsyringe at the other end. Between the filter and the spike thereis a clamp. |
| Intended Use: | Intended to prepare and deliver small aliquots of filtered wholeblood, red blood cells, platelets plasma and cryoprecipitate forpediatric and/or neonatal transfusion. |
:
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Public Health Service
1 3: 2 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Blood Products Specialties LLC C/O Alan A. Waldman, Ph.D. Waldman Biomedical Consultancy, Incorporated 184 Seiffert Court Oceanside, New York 11572
Re: K050805
Trade/Device Name: Pedi-Syringe Filter™ Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: BRZ, FMF Dated: March 29, 2005 Received: March 30, 2005
Dear Dr. Waldman:
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 - Dr. Waldman
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 (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 vour 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
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): ____________________________________________________________________________________________________________________________________________________
Pedi-Syringe Filter™ Device Name:
Indications For Use: Blood Product Specialties Pedi-Syringe Filter™ is intended to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma and cryoprecipitate for pediatric and/or neonatal transfusion.
AND/OR Over-The-Counter Use Prescription Use _
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cuts Vm
(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital, Offision Control, Dental Devices
Number: KDS0895
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
§ 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.