(60 days)
Not Found
Not Found
No
The description focuses on the mechanical components and function of a blood collection needle set, with no mention of AI or ML capabilities.
No
Explanation: The device is intended for blood collection, which is a diagnostic procedure, not a therapeutic intervention.
No
The text explicitly states that the device is "intended for blood collection via venipuncture". Blood collection is a sample collection process, not a diagnostic process itself.
No
The device description clearly states it is a physical blood collection needle set with tubing, an adapter, and a needle protector, indicating it is a hardware device.
Based on the provided information, the Safety-Multifly® is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "blood collection via venipuncture." This is a procedure to obtain a sample from the body, not to perform a diagnostic test on a sample outside the body.
- Device Description: The description details a blood collection needle set with features for safe collection and disposal. It does not describe a device that analyzes or tests a biological sample.
- Lack of Diagnostic Function: There is no mention of the device performing any kind of analysis, measurement, or testing of the collected blood. Its function is solely to facilitate the collection of the sample.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or screening purposes. The Safety-Multifly® is a tool for obtaining the specimen, not for performing the diagnostic test itself.
N/A
Intended Use / 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.
Product codes
FPA, JKA
Device Description
Not Found
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
all hospitals and/or practices where S-Monovettes are used.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its wings and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle image.
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.
1
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
2
ATTACHMENT I
Sanstedt, Inc. - P.O. Box 468 . Newton, NC 28658-0468
Image /page/2/Picture/3 description: The image is a black and white logo. The logo is a stylized letter "S" inside of a square. The letter "S" is slanted and has a small horizontal line at the top.
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