(60 days)
Not Found
No
The device description and intended use focus on mechanical components for blood collection and transfer, with no mention of AI or ML capabilities.
No
The device is a blood collection system used for drawing and transferring blood samples. It does not provide any therapeutic benefit to the patient.
No
The device is a blood collection system used to draw and transfer blood samples to vacuum tubes. Its purpose is to facilitate the collection of biological samples, not to perform an analysis or diagnosis based on those samples.
No
The device description clearly outlines physical components such as IV tubing, Luers, clamps, needles, and a Saf-T Holder® Device, indicating it is a hardware-based medical device.
Based on the provided information, the Saf-T Closed Blood Collection System® is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use of this device is to collect and transfer blood samples from a patient. It is a tool for obtaining the sample, not for performing a diagnostic test on the sample itself.
- Device Description: The description details the components and how the device is used to draw blood and transfer it to vacuum tubes. It does not describe any components or processes related to analyzing the blood sample for diagnostic purposes.
- Lack of Diagnostic Function: The device facilitates the collection and transfer of blood, which is a necessary step for many diagnostic tests, but it does not perform any analysis or provide any diagnostic information about the blood.
- Predicate Devices: The predicate devices listed are also blood collection and transfer devices, not IVD devices.
In summary, the Saf-T Closed Blood Collection System® is a medical device used for the collection and handling of blood samples, but it does not meet the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
REF Code 99200 and 99300
Device Name: Saf-T Closed Blood Collection System® with Saf-T Holder® Device and Male Luer Connector
Indications for Use:
The Saf-T Closed Blood Collection System® is attached to a peripheral IV catheter at the time of IV catheter placement to allow syringe blood draw and transfer to fill vacuum tubes.
REF Code 992XX
Device Name: Saf-T Closed Blood Collection System® with Saf-T Holder® and Saf-T Wing® Device
Indications for Use:
The Saf-T Closed Blood Collection System® is intended for use as syringe blood draw device and sample transfer device from a syringe to a vacuum tube.
Product codes (comma separated list FDA assigned to the subject device)
JKA
Device Description
The Saf-T Closed Blood Collection System® is a venous blood drawing device that consists of three distinct configurations with distinct uses as follows.
- REF Code 99200: Syringe line draw and transfer
This device consists of IV tubing with a male and female Luer, clamps to control blood flow, and a Saf-T Holder® Device.
- The male Luer is attached to a peripheral IV catheter hub at the time of IV . catheter insertion.
- A sample syringe is attached to the female Luer to collect the blood sample. .
- Transfer from the sample syringe is accomplished by inserting vacuum tubes into . the Saf-T Holder® device.
- REF Code 992XX*: Syringe draw and transfer via Saf-T Wing® access
*XX corresponds to the needle gauge, example: REF 99223 is the 23G needle This device consists of IV tubing with a female Luer , clamps to control blood flow, a Saf-T Wing® needle and a Saf-T Holder® Device. The Saf-T Wing® needle is offered in three sizes: 21G, 23G, 25G all 3/4" long.
- · The vein is accessed via the Saf-T Wing® needle
- · Blood is drawn into a syringe which is attached to the female Luer
- · The blood sample is then transferred from the syringe by inserting vacuum tubes into the Saf-T Holder® device.
- REF Code 99300: Syringe line draw, transfer and flush
This device consists of IV tubing with a male Luer, two female Luers , clamps to control blood flow, and a Saf-T Holder® Device.
- · The male Luer is attached to a peripheral IV catheter hub at the time of IV catheter insertion.
- · A sample syringe is attached to the female Luer to collect the blood sample.
- · A pre-filled flush syringe is attached to the second female Luer.
- · The blood sample is then transferred from the syringe by inserting vacuum tubes into the Saf-T Holder® device.
- · The catheter is flushed using the attached pre-filled syringe
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
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)
Non-Clinical Data:
Bench testing confirms that the proposed device and the predicate device have similar performance specifications.
Clinical Data:
Not Required
Conclusion:
The bench testing conducted demonstrates that the proposed device is safe and effective and is substantially equivalent to the predicate device.
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.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
SECTION 5, 510(k) Summary
Company Information:
Smiths Medical ASD, Inc. 10 Bowman Drive Keene, NH 03431 (603) 352-3812, prompt 4, ext 2493 Contact: Brian D. Farias Regulatory Affairs Manager
NOV 2 4 2007
072783
P I
Summary Prepared: September 28, 2007 (Revised November 21, 2007)
Product Name:
Trade Name: Saf-T Closed Blood Collection System®
Common Name: Venous Blood Collection Device
Classification Name: 862.1675 Blood Specimen Collection Device
Predicate Device(s):
K923090 (Ryan Medical - subsequently acquired from MPS Acacia by Smiths Medical ASD, Inc) Saf-T Holder multi sample Luer adapter with blood
K895705 (Ryan Medical - subsequently acquired from MPS Acacia by Smiths Medical ASD, Inc) Shamrock Safety Blood Collection Set
K895367 (Medical Product Specialists) Intravenous Extension Set
MPS Acacia marketed the Saf-T Closed Blood Collection System® under the trade name CVSC Closed Venous Blood Sample Collection System. MPS Acacia wrote a "letter to file" which identifies the above 510(k)'s and is found in attachment 1.
1
Device Description:
The Saf-T Closed Blood Collection System® is a venous blood drawing device that consists of three distinct configurations with distinct uses as follows.
1. REF Code 99200: Syringe line draw and transfer
This device consists of IV tubing with a male and female Luer, clamps to control blood flow, and a Saf-T Holder® Device.
- The male Luer is attached to a peripheral IV catheter hub at the time of IV . catheter insertion.
- A sample syringe is attached to the female Luer to collect the blood sample. .
- Transfer from the sample syringe is accomplished by inserting vacuum tubes into . the Saf-T Holder® device.
2. REF Code 992XX*: Syringe draw and transfer via Saf-T Wing® access
*XX corresponds to the needle gauge, example: REF 99223 is the 23G needle This device consists of IV tubing with a female Luer , clamps to control blood flow, a Saf-T Wing® needle and a Saf-T Holder® Device. The Saf-T Wing® needle is offered in three sizes: 21G, 23G, 25G all 3/4" long.
- · The vein is accessed via the Saf-T Wing® needle
- · Blood is drawn into a syringe which is attached to the female Luer
- · The blood sample is then transferred from the syringe by inserting vacuum tubes into the Saf-T Holder® device.
3. REF Code 99300: Syringe line draw, transfer and flush
This device consists of IV tubing with a male Luer, two female Luers , clamps to control blood flow, and a Saf-T Holder® Device.
- · The male Luer is attached to a peripheral IV catheter hub at the time of IV catheter insertion.
- · A sample syringe is attached to the female Luer to collect the blood sample.
- · A pre-filled flush syringe is attached to the second female Luer.
- · The blood sample is then transferred from the syringe by inserting vacuum tubes into the Saf-T Holder® device.
- · The catheter is flushed using the attached pre-filled syringe
2
Indications for Use:
Image /page/2/Picture/1 description: The image shows handwritten text on a white background. The text at the top appears to be a code or identifier, reading 'K072753'. Below this, there is another line of text that reads 'P3'. The handwriting is somewhat rough, with the numbers and letters not perfectly formed.
REF Code 99200 and 99300
Device Name: Saf-T Closed Blood Collection System® with Saf-T Holder® Device and Male Luer Connector
Indications for Use:
The Saf-T Closed Blood Collection System® is attached to a peripheral IV catheter at the time of IV catheter placement to allow syringe blood draw and transfer to fill vacuum tubes.
REF Code 992XX
Device Name: Saf-T Closed Blood Collection System® with Saf-T Holder® and Saf-T Wing® Device
Indications for Use:
The Saf-T Closed Blood Collection System® is intended for use as syringe blood draw device and sample transfer device from a syringe to a vacuum tube.
Technological Characteristics:
The proposed and predicate devices have the same characteristics, i.e. vascular access via a peripheral IV catheter or a safety needle with tubing and clamps to control blood flow, Luers for syringe attachment and a Saf-T Holder® device for vacuum tube placement.
Non-Clinical Data:
Bench testing confirms that the proposed device and the predicate device have similar performance specifications.
Clinical Data:
Not Required
Conclusion:
The bench testing conducted demonstrates that the proposed device is safe and effective and is substantially equivalent to the predicate device.
Very truly yours,
SMITHS MEDICAL ASD, INC.
Brian D. Farias
Regulatory Affairs Manager
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name in a circular arrangement around a symbol. The symbol consists of four stylized human figures, representing the department's focus on health and human well-being. The seal is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 3 0 2007
Mr. Brain D. Farias Regulatory Affairs Manager Smiths Medical ASD, Incorporated 10 Bowman Drive Keene, New Hampshire 03431
Re: K072783
Trade/Device Name: REF Code 99200: Saf-T Closed Blood Collection System® with Saf-T Holder® Device and male Luer Connector
REF Code 992XX: Saf-T Closed Blood Collection System® with Saf-T Holder® and Saf-T Wing® Device
REF Code 99300: Saf-T Closed Blood Collection System® with Saf-T Holder® Device and male Luer Connector
Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: II Product Code: JKA Dated: September 28, 2007 Received: October 2, 2007
Dear Mr. Farias:
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.
4
Page 2 - Mr. Farias
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.
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 (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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
CARS
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
5
SECTION 4, Indications for Use Statement
Indications for Use
510(k) Number (if known): K072783
REF Code 99200 and 99300
Device Name: Saf-T Closed Blood Collection System® with Saf-T Holder® Device and Male Luer Connector
Indications for Use:
The Saf-T Closed Blood Collection System® is attached to a peripheral IV catheter at the time of IV catheter placement to allow syringe blood draw and transfer to fill vacuum tubes.
REF Code 992XX
Device Name: Saf-T Closed Blood Collection System® with Saf-T Holder® and Saf-T Wing® Device
Indications for Use:
The Saf-T Closed Blood Collection System® is intended for use as syringe blood draw device and sample transfer device from a syringe to a vacuum tube.
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
Over-The-Counter Use (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) Page 1 of 1 anthe 19 m (Division Sign-Off) Division of Anesthesiology, General Hospital nfection Control, Dental Devices 10(k) Number: K472787 9