(90 days)
No
The device description and performance studies focus on the mechanical design and function of a physical adapter for a syringe, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is an accessory to a syringe and acts as a guide for performing intradermal injections, controlling the depth and angle of needle insertion. It does not directly treat or diagnose a disease or condition.
No
Explanation: The device is an accessory to a syringe designed to guide intradermal injections and control needle depth and angle. Its intended use is for administering injections, not for diagnosing conditions or diseases.
No
The device description explicitly states it is a single injection molded part manufactured from medical grade polycarbonate, which is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to act as a guide for performing intradermal injections on patients. This is a procedure performed on the patient's body, not on a sample taken from the patient's body.
- Device Description: The device is an accessory to a syringe, designed to control the depth and angle of needle insertion. This is a physical tool used in a medical procedure.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting substances, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications 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 year to adults, as a guide for performing intradermal injections.
Product codes
FMF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
children 2 year to adults
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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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.
1
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
2
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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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
4
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 Substantially
Equivalent Product West
Intradermal Adapter
K123588 | Proposed Device
Intradermal Adapter
Subject 510(k) | Comparison |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication 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 | The Intradermal Adapter is
an accessory to a 1ml, ½
inch fixed- needle allergy
syringe indicated for use
on patients ranging from
infants to adults, as a guide
for performing intradermal
injections. | Modified
Only patient population
has changed. The form
and function of the
proposed device has not
been modified from the
predicate device in order to
incorporate an expanded
patient population |
| Sterilization Method | Sterile Ethylene Oxide
SAL 10-6 | Sterile Ethylene Oxide
SAL 10-6 | Identical |
| Single use | Yes | Yes | Identical |
| Control of Injection
Depth | Design of Intradermal
Adapter limits the
exposed needle of the
compatible piston | Design of Intradermal
Adapter limits the
exposed needle of the
compatible piston | Identical |
5
West Intradermal Adapter
Traditional 510(k)
West Pharmaceutical Services, Inc.
| Areas for comparison | Claimed Substantially
Equivalent Product West
Intradermal Adapter
K123588 | Proposed Device
Intradermal Adapter
Subject 510(k) | Comparison |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|------------|
| | syringe to control depth
and angle of injection | syringe to control depth
and angle of injection | |
| Material | Polycarbonate | Polycarbonate | Identical |
| Type of Injection and
needle gauge size | Intradermal Compatible
with 27-29 gauge
needles | Intradermal Compatible
with 27-29 gauge
needles | Identical |
| Delivery form and
dosing system | Manual, using syringe
with Intradermal
Adapter (Utilizes
standard syringe-vial
dosing system) | Manual, using syringe
with Intradermal
Adapter (Utilizes
standard syringe vial
dosing system) | Identical |
| Compatible Syringe
type | Adapter fits to piston
syringe barrel - 1 ml
disposable, ½ inch, 27g
to 29g fixed needle
syringe | Adapter fits to piston
syringe barrel - 1 ml
disposable, ½ inch, 27g
to 29g fixed needle
syringe | Identical |
| Delivery form and
dosing system | Manual, using syringe
with Intradermal
Adapter (Utilizes
standard syringe-vial
dosing system) | Manual, using syringe
with Intradermal
Adapter (Utilizes
standard syringe vial
dosing 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
6
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.