(60 days)
The Safety-Multifly® is a winged blood collection needle set with flexible tubing, an adapter for the S-Monovette® system, and an integral needle protector. The Safety-Multifly® is intended for blood collection via venipuncture. The Safety-Multifly® needle protector, when activated after removal from the patient, covers the used needle until it can be properly disposed; therefore, aiding in the prevention of needle stick injuries.
The Safety-Multifly® is individually packaged. sterile, single-use and non-pyrogenic.
The Safety-Multifly® is intended to be used in all hospitals and/or practices where S-Monovettes are used.
The Safety-Multifly® is a winged blood collection needle set with flexible tubing, an adapter for the S-Monovette® system, and an integral needle protector.
This document is a 510(k) premarket notification acceptance letter for a medical device (Safety-Multifly®), not a study report. Therefore, it does not contain the detailed clinical trial or performance study information requested about acceptance criteria, device performance, sample sizes, ground truth establishment, or expert involvement.
Here's a breakdown of why the requested information cannot be extracted from the provided text:
- Type of Document: This is a regulatory approval letter from the FDA, confirming that the Safety-Multifly® device is "substantially equivalent" to legally marketed predicate devices. It is not a clinical study report or a detailed technical performance report.
- Focus of 510(k): The 510(k) process primarily focuses on demonstrating substantial equivalence to a predicate device, meaning it has the same intended use and technological characteristics, or different characteristics that do not raise new questions of safety and effectiveness. It often relies on comparisons to existing devices and bench testing rather than extensive new clinical trials, especially for Class II devices like this one.
Because the document only states that the device is "substantially equivalent" to predicate devices, it does not provide the specific data requested in your prompt. The FDA's determination of substantial equivalence implies that the device meets the safety and effectiveness standards comparable to the predicate device, but the details of how that was demonstrated (e.g., through specific acceptance criteria and a study) are not included in this letter.
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Public Health Service
SEP 1 2 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Peter Rumswinkel VP/ General Manager 1025 Street James Church Road PO Box 468 Newton, North Carolina 28658
Re: K032150
Trade/Device Name: Safety- Multifly Regulation Number: 880.5440, 862.1675 Regulation Name: Intravascular Administration Regulatory Class: II Product Code: FPA. JKA Dated: July 11, 2003 Received: July 14, 2Q03
Dear Mr. Rumswinkel:
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 - Mr. Rumswinkel
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 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 (301) 594-1418. 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/dsma/dsmamain.html
Sincerely yours,
Susan Runner
Susan Runner, DDS, MA Interim 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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ATTACHMENT I
Sanstedt, Inc. - P.O. Box 468 . Newton, NC 28658-0468
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Instruments and Disposables for Medicine and Science
Indications for Use Statement
510(k) Number: K032150
Device Name: Safety-Multifly®
Indications For Use:
The Safety-Multifly® is a winged blood collection needle set with flexible tubing, an adapter for the S-Monovette® system, and an integral needle protector. The Safety-Multifly® is intended for blood collection via venipuncture. The Safety-Multifly® needle protector, when activated after removal from the patient, covers the used needle until it can be properly disposed; therefore, aiding in the prevention of needle stick injuries.
The Safety-Multifly® is individually packaged. sterile, single-use and non-pyrogenic.
The Safety-Multifly® is intended to be used in all hospitals and/or practices where S-Monovettes are used.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) S Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
Patricia Lucente
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number:
Sarstedt Inc. P.O. Box 468 Newton, NC 28658-0468
(828) 465-4000 Corporate Telefax (828) 465-0718 Corporate (800) 257-5101 Sales Phone (828) 485-4003 Sales Telefax
§ 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.