(104 days)
The intended use of the Welmed, Inc. piston syringes is to inject fluids into or withdraw fluids from the body.
The Welmed, Inc. Syringe is a device intended for medical purposes, consisting of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male Luer Lock connector (nozzle) for attaching the female Luer connector (hub) of a hypodermic single lumen needle, or for attaching other devices with a female Luer.
Here's an analysis of the provided text regarding the Welmed Hypodermic Syringe, focusing on acceptance criteria and supporting studies.
Important Note: The provided document is a 510(k) summary for a medical device (hypodermic syringe), not an AI/software as a medical device (SaMD). Therefore, many of the requested categories related to AI development (e.g., sample sizes for training/test sets, expert adjudication, MRMC studies, ground truth establishment) are not applicable to this type of submission. The device is a physical product, and its performance is evaluated against established physical standards.
Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
The Welmed Hypodermic Syringe demonstrates conformance to the FDA-recognized consensus standard ISO 7886-1:1993, "Sterile hypodermic syringes for single use - Part 1: Syringes for manual use." This standard sets forth the acceptance criteria for various performance characteristics of manually operated hypodermic syringes.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from ISO 7886-1:1993, implied) | Reported Device Performance |
|---|---|
| Various physical and functional requirements for sterile hypodermic syringes for single use. This standard covers aspects such as: | Welmed Inc. has established that its family of syringes conform to ISO 7886-1:1993. Data supporting conformance is available from Welmed. |
| * Freedom from defects (e.g., burrs, foreign matter) | Conforms |
| * Dimensional accuracy (e.g., barrel diameter, plunger fit) | Conforms |
| * Performance characteristics (e.g., ease of gliding of plunger, liquid leakage, freedom of air and liquid from the plunger, plunger retention, scale legibility) | Conforms |
| * Sterility | Conforms |
| * Biocompatibility of materials | Conforms |
| * Packaging and labeling requirements | Conforms |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is a compliance study against the ISO 7886-1:1993 standard.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in the 510(k) summary. For physical device testing against an ISO standard, samples of each syringe size (1, 3, 5, 10, 20, 30, and 60 ml) would have been taken to perform the various tests outlined in the standard. The sample size would be determined by the specific requirements of ISO 7886-1:1993 for each test.
- Data Provenance: Not explicitly stated. For a 510(k) submission, the testing would typically be performed by the manufacturer, or a qualified third-party laboratory, in line with Good Manufacturing Practices (GMP) and relevant quality systems. Given the US submission, the testing would likely have been conducted in the US or a facility adhering to similar international standards. The data would be prospective as it's specifically generated for the purpose of demonstrating compliance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- N/A. This question is relevant to AI/SaMD devices where expert consensus is used to label data. For a physical device conforming to an ISO standard, "ground truth" is typically defined by the objective measurement and testing methods specified within the standard itself, performed by trained technicians or engineers, not by medical experts establishing diagnostic ground truth.
4. Adjudication Method for the Test Set
- N/A. Adjudication methods (like 2+1, 3+1) are used in AI/SaMD studies to resolve disagreements among human reviewers when establishing ground truth for diagnostic tasks. This is not applicable to the physical testing of a syringe against an ISO standard, where results are typically objective measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
- N/A. This is a question specifically for AI/SaMD comparative effectiveness studies and is not relevant to a physical medical device like a syringe.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- N/A. This is a question about AI algorithm performance. No algorithm is involved in the function of a manual hypodermic syringe.
7. The Type of Ground Truth Used
- The "ground truth" for the Welmed Hypodermic Syringe's performance is defined by the objective specifications and performance criteria laid out in the ISO 7886-1:1993 standard. This includes specific physical and functional tests, measurement tolerances, and material requirements. The results of these tests (e.g., leakage rate, gliding force, dimensional accuracy) directly constitute the "ground truth" for compliance.
8. The Sample Size for the Training Set
- N/A. There is no "training set" for a physical device like a syringe in the context of AI/machine learning. The device's design, manufacturing processes, and quality control are developed over time using engineering principles, not machine learning training.
9. How the Ground Truth for the Training Set Was Established
- N/A. As there is no training set in the AI/ML sense, this question is not applicable. The design principles and manufacturing specifications for the syringe are based on established engineering practices and the requirements of relevant standards like ISO 7886-1:1993.
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JUL 16 2007
Section 5: 510(k) Summary
| 1. Preparation Date: | March 30, 2007 |
|---|---|
| 2. Submitted by: | Welmed Inc.691 Lake StreetGrayslake, IL 60030 |
Contact Person/Prepared by:
Darren Reeves Management Representative Phone (866) 393-4954 Fax (866) 393-4954 E-mail: dpdist@bww.com
3. Device Identification:
| Trade Name: | Welmed Hypodermic Syringe (various sizes) |
|---|---|
| Common Name: | Syringes, Hypodermic |
| Classification Name: | Piston Syringe (21 CFR 880.5860; Product Code FMF) |
4. Predicate Device: Merit Medical Syringe (K024052)
5. Device Description:
The Welmed, Inc. Syringe is a device intended for medical purposes, consisting of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male Luer Lock connector (nozzle) for attaching the female Luer connector (hub) of a hypodermic single lumen needle, or for attaching other devices with a female Luer.
6. Intended Use:
The intended use of the Welmed, Inc. piston syringe is to inject fluids into or withdraw fluids from the body.
7. Statement to conform to ISO 7886-1; 1993
Welmed Inc. has established that its family of syringes corm to the FDArecognized consensus standard, ISO 7886-1:1993, Sterile hypodermic syringes for single use - Part 1: Syringes for manual use. Data supporting conformance with the standard is available from Welmed
- Conclusion - Based on conformance with the recommended standard, Welmed syringes are safe and effective for the intended use.
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9. Similarities/ Differences of the proposed device when compared to the predicate:
9.1.1 Intended Use
The Merit Medical syringes are intended to inject fluids into, or withdraw fluids from, the body. As such, the Intended Uses of the predicate and Welmed syringes are equivalent.
9.1.2 Materials
Materials used in the manufacture of Welmed syringes are typically used in the manufacture of general-purpose syringes, including the predicate device,
9.1.3 Design
The design of the Welmed syringe is typical for syringes, including that of the predicate.
9.1.4 Operational Principles
The Welmed syringe is manually operated by advancing and withdrawing the plunger in the barrel. The operating principles are identical for all manual syringes, including the predicate.
9.1.5 Technology
The same fundamental technology is used in the design of the Welmed syringes as is employed in the design of all manual syringes, including the predicate.
9.1.6 Safety and Performance
Welmed has provided a statement that its syringes conform to the requirements of IS0 7886-1 :I 993, an FDA- recognized consensus standard. This statement and the data that has been collected to support conformance has been used to demonstrate safety and performance in lieu of demonstrating substantial equivalence with the predicate device.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circle around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 16 2007
Welmed, Incorporated C/O Mr. Darren Reeves Management Representative DP Distribution and Consulting, LLC 15637 Fox Cove Circle Moseley, Virginia 23120
Re: K070936
Trade/Device Name: Welmed Hypodermic Syringes (1,3,5,10,20,30 and 60 ml) Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: May 23, 2007 Received: May 29, 2007
Dear Mr. Reeves:
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.
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.
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Page 2 - Mr. Reeves
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,
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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Food and Drug Administratio
ER FOR DEVICES AND RADIOLOGIC. FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Co
Indications for Use
510(k) Number (if known): K070936_________________________________________________________________________________________________________________________________________
Device Name: Welmed Hypodermic Syringes_
Indications for Use:
The intended use of the Welmed, Inc. piston syringes is to inject fluids into or withdraw fluids from the body.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
;
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re
Over-The-Counter Use (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)
signature
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: _ K4 7φ936
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§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).