(90 days)
The Intradermal Adapter is an accessory to a 1 ml, ½ inch fixed-needle allergy syringe indicated for use as a guide for performing intradermal injections.
The Intradermal Adapter consists of a single injection molded part manufactured from a medical grade polycarbonate. The Intradermal Adapter is a piston syringe accessory which is designed for use with 1ml allergy syringes with ½ inch (27g), (28g), (29g) needles, which are commonly used for intradermal injections given with a traditional Mantoux technique.
The Intradermal Adapter has been designed to snap-fit on to the end of the syringe forming an injection guide to control the depth and angle of needle insertion exposing only the minimal needle length required to perform a successful intradermal injection. The Intradermal Adapter is provided sterile in an individually packaged configuration.
The provided text describes the West Intradermal Adapter, a medical device, and its 510(k) submission. However, it does not contain specific acceptance criteria or detailed study results that would allow for a table of acceptance criteria and reported device performance. The information is high-level and broadly states that performance testing was conducted.
Here's an analysis based on the provided text, highlighting what is present and what is missing:
Acceptance Criteria and Study for West Intradermal Adapter
The provided 510(k) summary for the West Intradermal Adapter (K123588) broadly states that "Performance testing including bench, animal and simulated use was conducted to assess the safety and effectiveness of the Intradermal Adapter for the stated indications for use." It concludes that "Results of performance testing demonstrated that the Intradermal Adapter used as an accessory to the piston syringe is safe and effective in administering intradermal injections."
However, the document does not specify the acceptance criteria themselves, nor does it provide a detailed breakdown of the reported device performance against such criteria. Therefore, a table explicitly outlining acceptance criteria and reported performance cannot be constructed from the given text.
Below is a breakdown of the other requested information:
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Table of Acceptance Criteria and Reported Device Performance:
- Not provided in the document. The 510(k) summary states that performance testing (bench, animal, simulated use) was conducted and demonstrated safety and effectiveness, but it does not list specific quantitative or qualitative acceptance criteria, nor the detailed results achieved.
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Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not specified in the document.
- Data Provenance: The general categories of testing mentioned are "bench, animal and simulated use." The country of origin and whether the data was retrospective or prospective are not specified.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. Given the nature of a medical device accessory for injections, 'ground truth' in the AI/ML sense (e.g., expert consensus on image interpretation) is generally not applicable to this type of device submission. Performance testing for such devices typically involves assessing physical and functional attributes, not diagnostic accuracy requiring expert image review.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective interpretation (e.g., radiology reads) to establish ground truth or resolve discrepancies. For a physical medical device like an intradermal adapter, performance is usually evaluated against objective metrics (e.g., depth of penetration, stability, material integrity), not through human adjudication of interpretations.
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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:
- No, an MRMC study was not done. This type of study is relevant for AI-powered diagnostic tools where human readers are interpreting data with or without AI assistance. The West Intradermal Adapter is a physical accessory, not an AI diagnostic tool, so an MRMC study is not applicable.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device is a physical accessory, not an algorithm. Therefore, "standalone" algorithm performance is not a relevant concept for this product.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For a physical medical device, "ground truth" would be established through objective measurements and observations during bench testing (e.g., dimensional accuracy, material strength, leakage tests) and through direct assessment of injection performance in animal or simulated use models (e.g., successful intradermal bleb formation, correct depth of injection). The document broadly mentions "bench, animal and simulated use" but does not detail the specific performance metrics or how "ground truth" for those metrics was established.
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The sample size for the training set:
- Not applicable/Not provided. The device is a physical accessory, not an AI/ML model, so there is no "training set."
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How the ground truth for the training set was established:
- Not applicable. As there is no training set for a physical accessory device, the establishment of its ground truth is not relevant in this context.
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West Intradermal Adapter
Traditional 510(k) West Pharmaceutical Services, Inc.
510(k) Summary
FEB 1 9 2013
Device: Intradermal Adapter
Company Name:
WEST PHARMACEUTICAL SERVICES, INC. 101 Gordon Dr. Lionville, PA 19341
Contact Person: Kevin Lentz Director of Regulatory Affairs Phone: 610-594-4353 Fax: 610-594-3004 E-mail: kevin.lentz@westpharma.com
Preparation date: 19 November 2012
Classification:
Classification name: Trade name: Common/usual name: Product Code: Regulation No .: Class: Panel Identification:
Syringe, Piston (Accessory) Intradermal Adapter Intradermal Adapter (ID Adapter) FMF 21 CFR 880.5860 II General Hospital
BD-Microfine, Ultrafine; and Allergy Syringe K941657 Predicate Devices:
Device Description:
The Intradermal Adapter consists of a single injection molded part manufactured from a medical grade polycarbonate. The Intradermal Adapter is a piston syringe accessory which is designed for use with 1ml allergy syringes with ½ inch (27g), (28g), (29g) needles, which are commonly used for intradermal injections given with a traditional Mantoux technique.
The Intradermal Adapter has been designed to snap-fit on to the end of the syringe forming an injection guide to control the depth and angle of needle insertion exposing only the minimal needle length required to perform a successful intradermal injection. The Intradermal Adapter is provided sterile in an individually packaged configuration.
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West Intradermal Adapter
Traditional 510(k)
West Pharmaceutical Services, Inc.
Indications for Use:
The Intradermal Adapter is an accessory to a 1 ml, ½ inch fixed-needle allergy syringe indicated for use as a guide for performing intradermal injections.
Technological Characteristics and Substantial Equivalence:
The Intradermal Adapter utilized as an accessory to the piston syringe has the same intended purpose and principle of operation as the predicate device with respect to performing an injection below the surface of the skin including intradermally and is therefore substantially equivalent to the cleared device referenced: K941657 (BD Microfine, Ultrafine, and Allergy Syringe).
Performance Testing:
Performance testing including bench, animal and simulated use was conducted to assess the safety and effectiveness of the Intradermal Adapter for the stated indications for use. Results of performance testing demonstrated that the Intradermal Adapter used as an accessory to the piston syringe is safe and effective in administering intradermal injections.
Conclusion:
Comparative analysis of the technological characteristics between the proposed and predicate device and results of verification testing performed demonstrate that the subject device is substantially equivalent to the legally marketed predicate device. Any differences between the proposed and predicate device do not raise any additional concerns regarding safety and effectiveness; therefore the Intradermal Adapter used as an accessory to the disposable allergy syringe may be considered substantially equivalent to the predicate device.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and features the department's name around the perimeter. In the center is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with a more abstract and modern design. The symbol is composed of three curved lines that form a wing-like shape.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
February 19, 2013
Mr. Kevin Lentz Director of Regulatory Affairs West Pharmaceutical Services, Incorporated 101 Gordon Drive Lionville, Pennsylvania 19341
Re: K123588
Trade/Device Name: Intradermal Adapter Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: November 19, 2012 Received: November 21, 2012
Dear Mr. Lentz:
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.
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Page 2 - Mr. Lentz
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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
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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
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West Intradermal Adapter
Indications for Use
510(k) Number (if known): ¥123 588
Device Name: Intradermal Adapter
Indications for Use:
The Intradermal Adapter is an accessory to a 1 ml, ½ inch fixed-needle allergy syringe indicated for use as a guide for performing intradermal injections.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
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)
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ifection Control, Dental Devices
| 510(k) Number | K123588 |
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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).