(128 days)
No
The device description and performance studies focus on the mechanical function and physical properties of a blood collection holder, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as a holder used to fill blood into blood culture bottles and tubes during routine venipuncture procedures. Its function is to facilitate blood collection, not to treat or diagnose a disease or condition.
No
The device is described as an external holder used to facilitate the collection of blood into blood culture bottles and tubes. It does not come into contact with the blood specimen and its function is purely for the mechanical support and connection of other blood collection components. It does not perform any analysis or provide any diagnostic information.
No
The device description clearly outlines physical components made of plastic and used in a venipuncture procedure, indicating it is a hardware device. There is no mention of software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to facilitate the collection of blood into blood culture bottles and tubes during routine venipuncture. It is a tool for sample collection, not for performing a diagnostic test on the collected sample.
- Device Description: The description explicitly states that the Blood Culture Holder "does not come into contact with the blood specimen." It is an external holder for other components that do contact the blood. IVD devices typically interact directly with the biological specimen to perform a test or analysis.
- Function: The device's function is purely mechanical – holding and connecting components for blood collection. It does not contain reagents, perform measurements, or analyze the blood in any way.
While the collected blood will be used for in vitro diagnostic testing (blood cultures), the Blood Culture Holder itself is a blood collection accessory and not an IVD device.
N/A
Intended Use / Indications for Use
The Blood Culture Holder is used to fill blood into blood culture bottles and tubes in routine venipuncture procedures. This device is to be used by properly trained healthcare professionals only in accordance with these instructions.
The SAFETY Blood Collection Set and/or Blood Collection Set + Blood Culture Holder are used in routine venipuncture procedures. The winged needle of the SAFETY Blood Collection Set is designed with a while shield, which can be activated to cover the needle immediately following blood collection to aid in the protection against accidental needlestick injury. The Blood Culture Holder is used to fill blood into blood culture bottles and tubes.
Product codes
JKA
Device Description
Blood Culture Holder:
The Blood Culture Holder is used to fill blood into blood culture bottles and tubes in routine venipuncture procedures. This device is to be used by properly trained healthcare professionals only in accordance with these instructions.
Safety Blood Collection Set and/or Blood Collection Set + Blood Culture Holder:
The SAFETY Blood Collection Set and/or Blood Collection Set + Blood Culture Holder are used in routine venipuncture procedures. The winged needle of the SAFETY Blood Collection Set is designed with a safety shield, which can be activated to cover the needle immediately following blood collection to aid in the protection against accidental needlestick injury. The Blood Culture Holder is used to fill blood into blood culture bottles and tubes.
The Blood Culture Holder is a single-use, non-sterile, plastic holder with threads which are compatible with male luer adapters. The holder can be used with all VACUETTE Multiple Sample Luer Adapters and Safety Blood Collection Sets for routine venipuncture into various manufacturers' evacuated blood culture bottles and tubes. It is supplied alone or with the Greiner sterile Safety Blood Collection Set with Luer Adapter.
The Blood Culture Holder does not come into contact with the blood specimen. It is an external holder for the Safety Blood Collection Set and the VACUETTE Multiple Sample Luer Adapter. The Safety Blood Collection Set consists of tubing with a blood collection needle at one end and a female luer at the other. The VACUETTE Multiple Sample Luer Adapter consists of a male luer at one end and a cannula covered with a sheath. The luer adapter is threaded into the Blood Culture Holder, with the male luer end on the outside and the covered cannula on the inside of the holder barrel. The blood flows through the blood collection needle and tubing of the Safety Blood Collection Set, into the male luer of the VACUETTE Multiple Sample Luer Adapter, through the luer into the cannula, and into the blood culture tube or holder when punctured by the cannula. The fluid path consists of the Safety Blood Collection Set and the VACUETTE Multiple Sample Luer Adapter. The Blood Culture Holder never comes into contact with the blood specimen during conditions of use.
When the Blood Culture Holder is supplied attached to the Safety Blood Collection Set and the VACUETTE Multiple Sample Luer Adapter, it undergoes sterilization as part of the entire system because the fluid path must be sterilized. However, when the Blood Culture Holder is provided alone, it is not sterilized and the user attaches their own sterile blood collection needle and luer adapter.
The Safety Blood Collection Set with Blood Culture Holder is non-pyrogenic and tested according to ISO-10993-11 rabbit pyrogen test. The devices also are below the limit for endotoxin and tested according to ISO-10993-11 LAL Turbidimetric Method.
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
properly trained healthcare professionals
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
Simulated blood draw testing was performed on the Safety Blood Collection Set with Luer Adapter and the Blood Culture Holder using a variety of blood culture bottles and evacuated tubes representing the range of bottle and tube sizes.
- Blood collection devices: Greiner Safety Blood Collection Set with Luer . Adapter; Blood Culture Holders;
- Blood culture bottles and vials (2 manufacturers); .
- Blood collection tubes: VVACUETTE EDTA K2, 4 mL, 13x75mm (smallest diameter cap and tube size) and VACUETTE Z Serum . Separator and Clot Activator, 7 mL, 16x100mm (largest diameter cap and tube size).
Twenty Blood Culture Holders were connected to 20 Safety Blood Collection . Sets with Luer Adapters. The sets were tested in simulated blood draws with blood culture bottles, blood culture vials, and the two tube types.
The results were evaluated for proper fit of the Blood Culture Holders to the Safety Blood Collection Sets, leakage and function of the blood culture containers, and leakage and function of the blood collection tubes. All Blood Culture Holders met the acceptance criteria for fit, leakage, and function when connected to the Safety Blood Collection Sets and when used for blood collection into blood culture bottles and tubes.
Conclusion: The Blood Culture Holder can be used with blood culture bottles, blood culture vials, and the range of blood collection tube sizes from 13x75mm to 16x100mm.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K122687 510(K) SUMMARY
December 7. 2012
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is:
CONTACT:
Manfred Abel Greiner Bio-One North America, Inc. P.O Box 1026 Monroe, NC 28111
NAME OF DEVICE: Trade Name:
Common Names/Descriptions: Classification Name:
Product Code:
Class:
Blood Culture Holder; Safety Blood Collection Set + Luer Adapter with preattached Blood Culture Holder
Tube Holder
21 CFR 862.1675 Blood specimen collection device
JKA
ll
PREDICATE DEVICE:
Smiths Medical ASD Inc. Saf-T Closed Blood Collection System® (K081229)
DEVICE DESCRIPTION: INTENDED USE:
Blood Culture Holder:
The Blood Culture Holder is used to fill blood into blood culture bottles and tubes in routine venipuncture procedures. This device is to be used by properly trained healthcare professionals only in accordance with these instructions.
Safety Blood Collection Set and/or Blood Collection Set + Blood Culture Holder:
The SAFETY Blood Collection Set and/or Blood Collection Set + Blood Culture Holder are used in routine venipuncture procedures. The winged needle of the SAFETY Blood Collection Set is designed with a safety shield, which can be activated to cover the needle immediately
1
following blood collection to aid in the protection against accidental needlestick injury. The Blood Culture Holder is used to fill blood into blood culture bottles and tubes.
PRODUCT DESCRIPTION:
The Blood Culture Holder is a single-use, non-sterile, plastic holder with threads which are compatible with male luer adapters. The holder can be used with all VACUETTE® Multiple Sample Luer Adapters and Safety Blood Collection Sets for routine venipuncture into various manufacturers' evacuated blood culture bottles and tubes. It is supplied alone or with the Greiner sterile Safety Blood Collection Set with Luer Adapter.
The Blood Culture Holder does not come into contact with the blood specimen. It is an external holder for the Safety Blood Collection Set and the VACUETTE® Multiple Sample Luer Adapter. The Safety Blood Collection Set consists of tubing with a blood collection needle at one end and a female luer at the other. The VACUETTE® Multiple Sample Luer Adapter consists of a male luer at one end and a cannula covered with a sheath. The luer adapter is threaded into the Blood Culture Holder, with the male luer end on the outside and the covered cannula on the inside of the holder barrel. The blood flows through the blood collection needle and tubing of the Safety Blood Collection Set, into the male luer of the VACUETTE® Multiple Sample Luer Adapter, through the luer into the cannula, and into the blood culture tube or holder when punctured by the cannula. The fluid path consists of the Safety Blood Collection Set and the VACUETTE® Multiple Sample Luer Adapter. The Blood Culture Holder never comes into contact with the blood specimen during conditions of use.
When the Blood Culture Holder is supplied attached to the Safety Blood Collection Set and the VACUETTE® Multiple Sample Luer Adapter, it undergoes sterilization as part of the entire system because the fluid path must be sterilized. However, when the Blood Culture Holder is provided alone, it is not sterilized and the user attaches their own sterile blood collection needle and luer adapter.
The Safety Blood Collection Set with Blood Culture Holder is non-pyrogenic and tested according to ISO-10993-11 rabbit pyrogen test. The devices also are below the limit for endotoxin and tested according to ISO-10993-11 LAL Turbidimetric Method.
Caution: US Federal law restricts this device for sale by or on the order of a physician.
2
SUBSTANTIAL EQUIVALENCE:
The Blood Culture Holder is substantially equivalent to the Smiths Medical ASD Inc. Saf-T Closed Blood Collection System® (K081229) in intended use and design. The similarities and differences are listed below.
| | Greiner GBO
Blood Culture Holder | Smiths Medical ASD Inc.
Saf-T Closed Blood Collection System®
(predicate device) |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | Blood Culture Holder: K122687
Safety Blood Collection Set with
Luer Adapter: K011786 | K081229 |
| Intended Use | The Blood Culture Holder is used to
fill blood into blood culture bottles
and tubes in routine venipuncture
procedures. This device is to be
used by properly trained healthcare
professionals only in accordance
with these instructions. | The Saf-T Closed Blood
Collection System® device is
intended for use as a direct
blood draw device into a
vacuum tube or to allow a
syringe blood draw and
transfer to fill vacuum tubes. |
| Device
Description | Blood culture holder | Blood culture device |
| Device Design | Cylindrical holder for vacuum bottle
and tube placement : cylinder with
threads which are compatible with
male luer adapters
The design of the holder allows
collection of blood into blood culture
bottles and blood collection tubes. | Cylindrical holder for vacuum
bottle and tube placement :
cylinder with threads which
are compatible with blood
collection needles and male
luer adapters |
| Cylinder | Plastic | Plastic |
PRODUCT PERFORMANCE:
Simulated blood draw testing was performed on the Safety Blood Collection Set with Luer Adapter and the Blood Culture Holder using a variety of blood culture bottles and evacuated tubes representing the range of bottle and tube sizes. The devices used in the study were:
- Blood collection devices: Greiner Safety Blood Collection Set with Luer . Adapter; Blood Culture Holders;
- Blood culture bottles and vials (2 manufacturers); .
- Blood collection tubes: VVACUETTE® EDTA K2, 4 mL, 13x75mm
(smallest diameter cap and tube size) and VACUETTE® Z Serum .
3
Separator and Clot Activator, 7 mL, 16x100mm (largest diameter cap and tube size).
Twenty Blood Culture Holders were connected to 20 Safety Blood Collection . Sets with Luer Adapters. The sets were tested in simulated blood draws with blood culture bottles, blood culture vials, and the two tube types.
The results were evaluated for proper fit of the Blood Culture Holders to the Safety Blood Collection Sets, leakage and function of the blood culture containers, and leakage and function of the blood collection tubes. All Blood Culture Holders met the acceptance criteria for fit, leakage, and function when connected to the Safety Blood Collection Sets and when used for blood collection into blood culture bottles and tubes.
Conclusion: The Blood Culture Holder can be used with blood culture bottles, blood culture vials, and the range of blood collection tube sizes from 13x75mm to 16x100mm.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol associated with medicine and healthcare.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 10, 2013
Greiner Bio-One North America, Incorporated C/O Ms. Judith Smith Principal Judi Smith, Limited Liability Company P.O. Box 103 BALDWIN MD 21013
Re: K122687
Trade/Device Name: Blood Culture Holder Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: II Product Code: JKA Dated: December 17, 2012 Received: December 20, 2012
Dear Ms. Smith:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
5
Page 2 - Ms. Smith
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Anthony Lo Re
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
INDICATIONS FOR USE
510(k) Number (if known): K122687
Device Name: Blood Culture Holder
Indication For Use:
The Blood Culture Holder is used to fill blood into blood culture bottles and tubes in routine venipuncture procedures. This device is to be used by properly trained healthcare professionals only in accordance with these instructions.
The SAFETY Blood Collection Set and/or Blood Collection Set + Blood Culture Holder are used in routine venipuncture procedures. The winged needle of the SAFETY Blood Collection Set is designed with a while shield, which can be activated to cover the needle immediately following blood collection to aid in the protection against accidental needlestick injury. The Blood Culture Holder is used to fill blood into blood culture bottles and tubes.
Prescription Use × (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Weihong Gu -S c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, cn=Weihong Gu -S, 0.9.2342.19200300.100.1.1=2000380818 2013.01.11 11:49:54 -05'00'
Division Sign-Off Office of Device Evaluation
510(k) K122687
Page 1 of 1