(201 days)
Not Found
No
The device description and intended use focus on mechanical components for blood collection and do not mention any AI/ML capabilities.
No
The device is described as a "Blood Collection System" used for venipuncture and holding needles, which are procedures for collecting blood, not for treating a condition or disease.
No
Explanation: The device is a blood collection system used for venipuncture, which is a procedure to draw blood. It is not used to diagnose a medical condition based on the collected blood or any other input.
No
The device description clearly outlines physical components (sterile Luer holder, sterile Luer adapter, sterile hypodermic needle) and describes their physical interaction and function in blood collection. There is no mention of software as a component or the primary function of the device.
Based on the provided information, the SecuMax™ Blood Collection System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the collection of blood during venipuncture. This is a procedure to obtain a sample, not to perform a diagnostic test on the sample itself.
- Device Description: The device consists of components for blood collection (needle, adapter, holder). It does not contain reagents, test strips, or any other elements used for analyzing the blood sample to diagnose a condition.
- Lack of Diagnostic Function: The description focuses on the mechanics of blood collection and the design of the components for that purpose. There is no mention of any diagnostic capability or analysis of the blood.
IVD devices are specifically designed to perform tests on samples (like blood, urine, tissue) outside of the body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The SecuMax™ Blood Collection System is a tool for obtaining the sample, which might then be used in an IVD test, but it is not an IVD itself.
N/A
Intended Use / Indications for Use
The SecuMax™ Blood Collection System is a sterile and single-use package consisting of a Luer sterile holder with a Luer adapter to hold Exel hypodermic needles during venipuncture. The entire device will be disposed as a unit in a sharps container.
Product codes
FMI
Device Description
The SecuMax ™ Blood Collection System is a single-use sterile blood collection system. There are three main components in the package, i.e., sterile hypodermic needle, sterile Lucr adapter, and sterile Luer type holder. Special N-typed ergonomic lucr adapter can eliminate the collection angle by placing the nearly parallel with the arm. The special design luer adapter can be used with any size of hypodermic needle. Push-off Luer holder is designed to fit N-typed luer adapter. I The hypodermic needle used is Exel International disposable hypodermic needles with 10K # 861153
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)
Bench, pyrogen test, sterility, substantial equivalence, and simulated clinical testing are employed upon submission of this 510(K) premarket notification according to the General Guidance document provided by CDRH/ FDA.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).
0
K032/41
JAN 2 8 2004
510(K) Summary of Safety and Effectiveness (Per 21 II. CFR 807.92)
- General Information
Establishment
| Manufacturer: | Tiger Meditech Incorporated | |
|---|---|---|
| Address: | 12F, No. 130, Chung-Hsiao E. Rd. Sec. 2 | |
| Taipei 100 Taiwan | ||
| Registration Number: | 3004022299 | |
| Contact Person: | Kc-Min Jen | |
| Dr. | ||
| Official Correspondent | ||
| 886-3-5208829 (Tel) | ||
| 886-3-5209783 (Fax) | ||
| Date Prepared: | October 19, 2003 | |
| Device | ||
| Proprietary Name: | SecuMax™ | |
| Blood | ||
| Meditech | ||
| Tiger | ||
| Collection System | ||
| Common Name: | Vacutainer System | |
| Classification Name: | Tubes, Vials, Systems, Serum Separators, | |
| Blood Collection, Class II, JKA | ||
Safety and Effectiveness Information 2.
- Predicate Device: .
Claim of Substantial Equivalence (SE) is made to Becton Dickinson Vacutainer Systems (K980098)
1
Device Description: ●
The SecuMax ™ Blood Collection System is a single-use sterile blood collection There are three main components in the package, i.e., sterile hypodermic system. needle, sterile Lucr adapter, and sterile Luer type holder. Special N-typed ergonomic lucr adapter can eliminate the collection angle by placing the nearly parallel with the arm. The special design luer adapter can be used with any size of hypodermic needle. Push-off Luer holder is designed to fit N-typed luer adapter. I The hypodermic needle used is Exel International disposable hypodermic needles with ર 10K # 861153
Intended Use: .
The SecuMax™ Blood Collection System is a sterile and single-use package consisting of a sterile Luer holder with a sterile Luer adapter to hold Exel hypodermic needles during venipuncture.
Synopsis of Test Methods and Results ●
Bench, pyrogen test, sterility, substantial equivalence, and simulated clinical testing are employed upon submission of this 510(K) premarket notification according to the General Guidance document provided by CDRH/ FDA.
● Substantial Equivalence (SE)
A claim of substantial equivalence is made to Becton Dickinson Vacutainer Systems (K980098). The Tiger Meditech SecuMax™ Blood Collection System and the Becton Dickinson Vacutainer Systems both offer a simple and effective way to collect blood. The Tiger Meditech SecuMax™ Blood Collection System utilizes multi-sample Luer adapter with sterile Luer holder and hypodermic needle. The
5
2
Becton Dickinson Vacutainer Systems utilizes conventional straight holder and hypodermic needle. The intended purposes of both Tiger Meditech SecuMax™ Blood Collection System and the Becton Dickinson Vacutainer Systems are to collect blood while dispose the entire device as a unit in a sharps container.
Ke-Min Jen, Dr. Official Correspondent for Tiger Meditech Incorporated
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized caduceus-like symbol with three lines extending from a central point. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 8 2004
Tiger Meditech Incorporated C/O Dr. Shu-Chen Cheng ROC Chinese-European Industrial Research Society 2064 Tamarin Drive Columbus, Ohio 43235
Re: K032141
Trade/Device Name: Tiger Meditech™ SecuMax Blood Collection System Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle-Accessory Regulatory Class: II Product Code: FMI Dated: October 29, 2003 Received: November 3, 2003
Dear Dr. Cheng:
Wc 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 receiced above and nave atte 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 Amendments, or to abylood and Cosmetic Act (Act) that do not require approval of a premarket the Fouchal application (PMA). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls providents of a registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
lf 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 (1 NIT), it may of casyon 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.
4
Page 2 - Dr. Cheng
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 Incall that ITDA has made a deceminations administered by other Federal agencies. of the Act of ally I occar statutes and regurements, including, but not limited to: registration You must comply with an the Piece Stog (21 CFR Part 801); good manufacturing practice allo listing (21 CF RT Lev 007), as ality systems (QS) regulation (21 CFR Part 820); and if requirents as set forth in the quality ajons ontrol 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) I ins letter will anow you to objak finding of substantial equivalence of your device to a premarket notheation. - The FDF Imalis 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), II you desire specific advice to: Jour de at (301) 594-4618. 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 may obtain other general meeters, 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 vours,
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
K032/41
Indications for Use Statement IV.
Tiger Meditech Incorporated. Applicant:
510(k) Number: _K032141
Device Name: Tiger Meditech SecuMax™ Blood Collection System
Indications for Use:
The SecuMax™ Blood Collection System is a sterile and single-use package consisting of a Luer sterile holder with a Luer adapter to hold Exel hypodermic needles during venipuncture. The entire device will be disposed as a unit in a sharps container.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE.)
Prescription Use
OR
Over-The-Counter
Per 21 CFR 801.109
(Optional Format 1-2-96)
U.L. Hubbard, Interim Bureau Chief
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: