(90 days)
The Intradermal Adapter is an accessary to a 1ml, ½ inch fixed-needle allergy syringe indicated for use on patients ranging from children 2 year to adults, 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 510(k) premarket notification for the "Intradermal Adapter" device. Here's a breakdown of the acceptance criteria and study information:
Acceptance Criteria and Reported Device Performance
The document does not present a formal table of acceptance criteria with specific performance metrics and their corresponding reported values. Instead, it describes a qualitative acceptance based on the device's ability to maintain a controlled injection depth, similar to its predicate device, and the intended expansion of its indications for use.
The "Performance Testing" section states:
"Results of performance testing demonstrated that the Intradermal Adapter, when used as an accessory to the piston syringe, can be indicated for administering intradermal injections to the indicated patient population."
And regarding injection depth:
"...the peer reviewed studies presented in this submission confirm through the acquisition of data from 485 pediatric patients, that the controlled design of the ID Adapter prevents an injection depth to greater than 0.75mm which is well within the epidermis + dermis layer necessary for successful intradermal injection in a pediatric patient age group."
Based on this, we can infer the primary acceptance criterion and reported performance:
| Acceptance Criterion (Inferred) | Reported Device Performance |
|---|---|
| Controlled Injection Depth for Intradermal Injections | Prevents an injection depth greater than 0.75mm. This depth is "well within the epidermis + dermis layer necessary for successful intradermal injection." |
| Suitability for Expanded Patient Population (Pediatric) | Acceptable for use in expanded intended use applications for a wider patient age range, including pediatric patients over the age of 2 years. |
| Substantial Equivalence to Predicate Device | Demonstrated to be substantially equivalent to the legally marketed predicate device (K123588) based on technological characteristics and verification testing. |
Study Details:
-
Sample Size Used for the Test Set and the Data Provenance:
- Sample Size: 485 pediatric patients.
- Data Provenance: The data was acquired from "peer reviewed journal articles," indicating that the data is retrospective and originates from clinical research studies likely conducted in various countries/institutions depending on the journal articles cited. The document does not specify a single country of origin but refers to "medical literature obtained through peer reviewed journal articles."
-
Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- The document does not specify the number of experts or their qualifications for establishing ground truth for the test set from the peer-reviewed studies. It references "peer reviewed journal articles" which implies expert validation inherent in the peer-review process, but not specifically for defining ground truth for this device's submission.
-
Adjudication Method for the Test Set:
- The document does not mention a specific adjudication method like 2+1 or 3+1. The data was "acquired from medical literature" which would have established its own ground truth and validation methods within those original studies.
-
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed as described in this document. The study described focuses on device performance validation and comparison to Mantoux technique, not on human reader improvement with AI assistance.
-
If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
- This device is a physical medical device (an adapter for a syringe), not an AI algorithm. Therefore, a standalone performance study in the context of an algorithm's performance is not applicable and was not done.
-
The Type of Ground Truth Used:
- The ground truth for the injection depth was established through the "controlled design of the ID Adapter" and confirmed by clinical data from peer-reviewed studies demonstrating a consistent injection depth "well within the epidermis + dermis layer necessary for successful intradermal injection." This combines design specifications with clinical outcomes (successful intradermal injection).
-
The Sample Size for the Training Set:
- This document describes safety and performance testing for a physical medical device, not an AI/ML algorithm. Therefore, the concept of a "training set" as understood in machine learning is not applicable here. The device's design and engineering principles, informed by prior knowledge and the predicate device, serve a similar function as a "training" phase for an algorithm.
-
How the Ground Truth for the Training Set was Established:
- As stated above, the concept of a "training set" is not applicable. The device's design and functionality are based on principles established through prior engineering knowledge, the predicate device (K123588), and understanding of anatomical requirements for intradermal injections. The "ground truth" for its design and desired performance would have been established through biomechanical principles, anatomical knowledge, and validated clinical requirements for successful intradermal delivery.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 29, 2015
West Pharmaceutical Services Inc. Mr. Jeffrev Ravel Director, Regulatory Affairs 530 Herman O. West Drive Exton, Pennsylvania 19341
Re: K151777
Trade/Device Name: Intradermal Adapter Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: June 30, 2015 Received: July 1, 2015
Dear Mr. Ravel:
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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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Tina
Kiang -S
for Erin I. Keith, M.S. 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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Indications for Use
510(k) Number (if known) K151777
Device Name
Intradermal Adapter
Indications for Use (Describe)
The Intradermal Adapter is an accessary to a 1ml, ½ inch fixed-needle allergy syringe indicated for use on patients ranging from children 2 year to adults, as a guide for performing intradermal injections.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary
Device: Intradermal Adapter
Company Name:
West Pharmaceutical Services, Inc. 530 Herman O. West Drive Extron, PA 19341
Contact Person: Jeffrey Ravel Director of Regulatory Affairs Phone: 610-594-3482 Fax: 610-717-0668 E-mail: Jeffrey.Ravel@westpharma.com
Preparation date: 29 September 2015
Classification:
| Classification name: | Syringe, Piston (Accessory) |
|---|---|
| Trade name: | Intradermal Adapter |
| Common/usual name: | Intradermal Adapter (ID Adapter) |
| Product Code: | FMF |
| Regulation No.: | 21 CFR 880.5860 |
| Class: | II |
| Panel Identification: | General Hospital |
Predicate Devices: K123588 Intradermal Adapter
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
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West Intradermal Adapter
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.
Indication for Use:
The Intradermal Adapter is an accessary to a 1ml, ½ inch fixed-needle allergy syringe indicated for use on patients ranging from children 2 years old to adults, 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 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: K123588 (West Pharmaceutical Services - Intradermal Adapter).
| Areas for comparison | Claimed SubstantiallyEquivalent Product WestIntradermal AdapterK123588 | Proposed DeviceIntradermal AdapterSubject 510(k) | Comparison |
|---|---|---|---|
| Indication for Use | The Intradermal Adapter isan accessory to a 1 ml, ½inch fixed- needle allergysyringe indicated for use asa guide for performingintradermal injections | The Intradermal Adapter isan accessory to a 1ml, ½inch fixed- needle allergysyringe indicated for useon patients ranging frominfants to adults, as a guidefor performing intradermalinjections. | ModifiedOnly patient populationhas changed. The formand function of theproposed device has notbeen modified from thepredicate device in order toincorporate an expandedpatient population |
| Sterilization Method | Sterile Ethylene OxideSAL 10-6 | Sterile Ethylene OxideSAL 10-6 | Identical |
| Single use | Yes | Yes | Identical |
| Control of InjectionDepth | Design of IntradermalAdapter limits theexposed needle of thecompatible piston | Design of IntradermalAdapter limits theexposed needle of thecompatible piston | Identical |
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West Intradermal Adapter
Traditional 510(k)
West Pharmaceutical Services, Inc.
| Areas for comparison | Claimed SubstantiallyEquivalent Product WestIntradermal AdapterK123588 | Proposed DeviceIntradermal AdapterSubject 510(k) | Comparison |
|---|---|---|---|
| syringe to control depthand angle of injection | syringe to control depthand angle of injection | ||
| Material | Polycarbonate | Polycarbonate | Identical |
| Type of Injection andneedle gauge size | Intradermal Compatiblewith 27-29 gaugeneedles | Intradermal Compatiblewith 27-29 gaugeneedles | Identical |
| Delivery form anddosing system | Manual, using syringewith IntradermalAdapter (Utilizesstandard syringe-vialdosing system) | Manual, using syringewith IntradermalAdapter (Utilizesstandard syringe vialdosing system) | Identical |
| Compatible Syringetype | Adapter fits to pistonsyringe barrel - 1 mldisposable, ½ inch, 27gto 29g fixed needlesyringe | Adapter fits to pistonsyringe barrel - 1 mldisposable, ½ inch, 27gto 29g fixed needlesyringe | Identical |
| Delivery form anddosing system | Manual, using syringewith IntradermalAdapter (Utilizesstandard syringe-vialdosing system) | Manual, using syringewith IntradermalAdapter (Utilizesstandard syringe vialdosing system) | Identical |
| Syringe supply | Separate from the device | Separate from the device | Identical |
Performance Testing:
Performance testing including bench, animal, and simulated use was leveraged from the predicate K123588 submission. The data collected throughout the course of these studies included bevel up and bevel down configurations using 27g to 29g needles as compared to the Mantoux method. Information gathered from medical literature obtained through peer reviewed journal articles was obtained and used to support expanding the indications for use as the injection depth is properly controlled by the geometry of the ID Adapter indicating no compromise to the intended depth of penetration for the expanded patient population. Results of performance testing demonstrated that the Intradermal Adapter, when used as an accessory to the piston syringe, can be indicated for administering intradermal injections to the indicated patient population.
The peer reviewed studies presented in this submission confirm through the acquisition of data from 485 pediatric patients, that the controlled design of the ID Adapter prevents an injection
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West Intradermal Adapter
depth to greater than 0.75mm which is well within the epidermis + dermis layer necessary for successful intradermal injection in a pediatric patient age group. Based on the clinical journal data presented in this submission in conjunction with the visual references of injection application and physical limitations of the device, the ID Adapter is acceptable for use in expanded intended use applications for a wider patient age range including pediatric patients over the age of 2 years.
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.
§ 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).