ECOMED SCALP VEIN SET by GREINER MEDITECH, INC.

The Ecomed® Scalp Vein Set is a sterile winged needle bonded to a flexible tubing with a female luer adapter. The female luer is provided with a protective cap on the end.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Ecomed® Scalp Vein Set, focusing on its substantial equivalence to an existing device. However, it does not contain detailed information about specific acceptance criteria, comprehensive device performance data, or a study design as typically associated with proving a device meets acceptance criteria in a technical sense.

The document primarily focuses on:

Intended Use: Withdrawal of venous blood.
Material Equivalence: The Ecomed® needle is stainless steel, the same as the predicate device (Becton Dickinson's VACUTAINER® Brand Blood Collection Set). The needle protector sleeves and shields are also made from comparable materials (rubber and extruded plastic, respectively).
Biocompatibility Testing: Non-cytotoxicity was demonstrated in testing performed in accordance with ISO 10993, along with endotoxin testing. This is the closest mention of performance testing, but specific acceptance criteria or detailed results are not provided beyond "demonstrated."

Therefore, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Intended Use	Functionality as a winged blood collection needle for venous blood withdrawal.	Stated to have the "same intended use" as the predicate device (Becton Dickinson's VACUTAINER® Brand Blood Collection Set).
Material Composition	Needle material equivalent to predicate; protector sleeves and shields made of comparable materials.	Ecomed® needle is stainless steel, same as BD needle. Both protector sleeves are rubber. Both shields are extruded plastic.
Biocompatibility	Non-cytotoxic; acceptable endotoxin levels.	Non-cytotoxicity demonstrated per ISO 10993. Endotoxin testing also performed.
Sterility	Device is sterile.	Stated as a "sterile winged needle."

Note: The document provides very high-level assertions. Specific quantitative acceptance limits (e.g., maximum allowable cytotoxicity, specific endotoxin limits) and detailed performance results are not included in this summary.

2. Sample Size for Test Set and Data Provenance

Sample Size: Not specified in the provided text. The document only mentions that testing was performed (e.g., for non-cytotoxicity, endotoxin).
Data Provenance: Not specified. It does not mention country of origin or whether the data was retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth

Not applicable/Not mentioned. This type of information is typically relevant for studies involving human interpretation or subjective assessments (e.g., image-based diagnostics), which is not the primary focus of the information provided for this simple medical device. The "ground truth" for material equivalence or biocompatibility comes from standardized tests and material specifications.

4. Adjudication Method for Test Set

Not applicable/Not mentioned. Adjudication is typically used when multiple human experts provide opinions that need to be reconciled for a ground truth, which is not the case here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not performed or mentioned. This type of study is relevant for AI algorithms aiding human readers, which is not the nature of the Ecomed® Scalp Vein Set.

6. Standalone (Algorithm Only) Performance Study

No, a standalone performance study in the context of an "algorithm only" device was not performed or mentioned. The Ecomed® Scalp Vein Set is a physical medical device, not an AI algorithm.

7. Type of Ground Truth Used

The ground truth for the claims made (material equivalence, biocompatibility) would be based on:
- Manufacturer Specifications & Material Certificates: For material composition.
- Standardized Assay Results: For biocompatibility (e.g., ISO 10993 cytotoxicity assay results, endotoxin assay results).

8. Sample Size for the Training Set

Not applicable/Not mentioned. The Ecomed® Scalp Vein Set is a physical device, not a machine learning model, so there is no "training set."

9. How Ground Truth for the Training Set Was Established

Not applicable/Not mentioned (as there is no training set).

Summary

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OCT 1 4 1999

I. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Greiner Meditech, Inc. ("Greiner") is submitting a 510(k) premarket notification for the Ecomed Scalp Vein Set. The Ecomed® Scalp Vein Set is a sterile winged needle bonded to a flexible tubing with a female luer adapter. The female luer is provided with a protective cap on the end.

Greiner is claiming substantial equivalence to Becton Dickinson's VACUTAINER® Brand Blood Collection Set (K980414). Both scalp vein sets (butterfly needles) have the same intended use (i.e. withdrawal of venous blood) and contain the same material of the ECOMED® needle is stainless steel and is the same material used for the BD needle. Both the ECOMED® and BD needle protector sleeves covering the short end of the needle are made from rubber, and both the ECOMED® and BD needle shields are made from extruded plastic.

Non-cytotoxicity was demonstrated in testing which was performed in accordance with the ISO 10993, along with other tests such as endotoxin testing.

The ECOMED® Scalp Vein Set will be marketed separately and as a kit assembled with Greiner's 510k cleared VACUETTE® Holdex® holder (K980768).

Greiner's 510(k) has been submitted on June 25, 1999, by Douglas L. Harris, Managing Director, Greiner Meditech, Inc., 260 Gateway Drive, Suite 17A, Bel Air, Maryland, 21014 (410-836-8228).

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Image /page/1/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 depiction of an eagle with three swooping lines representing its wings and a wavy line representing its body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 4 1999

Mr. Douglas L. Harris Greiner Meditech, Inc. 260 Gateway Dr., Suite 17A Bel Air, MD 21014

Re : K992145 Ecomed® Scalp Vein Set Trade Name: Regulatory Class: II Product Code: FOZ September 15, 1999 Dated: Received: September 20, 1999

Dear Mr. Harris:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. ਉ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA

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Page 2 - Mr. Harris

may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

f. Susa Ruaros

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known) ________________

Device Name: ECOMED® Scalp Vein Set

Indications for Use: The Ecomed® Scalp Vein Set is a winged blood collection needle with a tubing used for the collection of venous blood.

Prescription Use X

Over-The Counter Use _________________________________________________________________________________________________________________________________________________________

Palacio Curente

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devic 510(k) Number ________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 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.