(201 days)
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. The entire device will be disposed as a unit in a sharps container.
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. The hypodermic needle used is Exel International disposable hypodermic needles with 510K # 861153.
The provided text describes a 510(k) premarket notification for the Tiger Meditech™ SecuMax Blood Collection System. The submission primarily focuses on establishing substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and performance data in the format typically seen for complex diagnostic devices.
Based on the provided information, I can extract the following:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics in the format of a table. The primary method for demonstrating safety and effectiveness is through a claim of "substantial equivalence" to a predicate device.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Bench Testing | Performed |
| Pyrogen Test | Performed |
| Sterility | Performed |
| Simulated Clinical Testing | Performed |
| Substantial Equivalence | Claimed to Becton Dickinson Vacutainer Systems (K980098) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a separate "test set" with a defined sample size for a performance study. It mentions "Bench, pyrogen test, sterility, substantial equivalence, and simulated clinical testing" as employed upon submission, but no details on sample size or data provenance (country of origin, retrospective/prospective) are provided for these tests. The focus is on comparing the characteristics of the new device to the predicate.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. The submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than establishing a new "ground truth" through expert consensus for performance evaluation. The "ground truth" implicitly lies with the predicate device's established safety and effectiveness.
4. Adjudication Method for the Test Set
Not applicable, as no specific test set requiring adjudication by experts is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. This type of study is more common for diagnostic imaging AI systems to assess human reader performance with and without AI assistance. The SecuMax™ Blood Collection System is a physical medical device.
6. Standalone Performance Study (Algorithm Only)
Not applicable. The SecuMax™ Blood Collection System is a physical blood collection system, not an algorithm, so a standalone algorithm-only performance study is not relevant. The studies performed (bench, pyrogen, sterility, simulated clinical testing) are evaluating the physical device and its properties.
7. Type of Ground Truth Used
The primary "ground truth" concept applied here is the established safety and effectiveness of the predicate device (Becton Dickinson Vacutainer Systems, K980098). The new device is deemed safe and effective if it can demonstrate substantial equivalence to this predicate. Where tests were performed (e.g., sterility, pyrogen), the "ground truth" would be established by standard scientific and regulatory methods for those specific tests.
8. Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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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 JenDr. | |
| Official Correspondent | ||
| 886-3-5208829 (Tel) | ||
| 886-3-5209783 (Fax) | ||
| Date Prepared: | October 19, 2003 | |
| Device | ||
| Proprietary Name: | SecuMax™BloodMeditechTiger | |
| 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)
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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
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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
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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.
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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
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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:
§ 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).