(146 days)
No
The device description and performance studies focus on a manual injection system and do not mention any AI or ML components or capabilities.
No.
The device is an injection system used to administer FDA approved drugs. It is a delivery system, not a therapeutic device itself.
No
The device is an injection system used for administering FDA approved drugs intradermally, not for diagnosing medical conditions.
No
The device description clearly states it is a physical system consisting of a needle and syringe, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the delivery of FDA approved drugs via intradermal injection. This is a therapeutic or drug delivery function, not a diagnostic one.
- Device Description: The device is described as a system for injection, consisting of a needle and syringe. This aligns with drug delivery devices.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (like blood, urine, or tissue) in vitro (outside the body) to diagnose a condition, monitor a disease, or screen for a disease.
- Performance Studies: The performance studies focus on the functionality of the injection system (wheal formation, injection depth) and its equivalence to predicate devices for drug delivery. There are no studies related to diagnostic accuracy or performance.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnostic purposes. This device's function is to administer a substance into the body.
N/A
Intended Use / Indications for Use
The Immucise Intradermal Injection System is indicated for intradermal injections of FDA approved drugs. The system is to be used in the deltoid region for infants aged two months (excluding low birth weight and/or preterm birth) to adults.
Product codes (comma separated list FDA assigned to the subject device)
FMI, FMF
Device Description
The Immucise Intradermal Injection System is a single use, electron beam radiation sterilized device that is designed to be used for intradermal injections of FDA approved drugs. This system consists of an Intradermal Injection Needle and an Immucise Syringe. The system is made of common materials used in needles and syringes. The Immucise Intradermal Injection Needle is comprised of a needle base. The Immucise Syringe is comprised of a barrel, a gasket and a plunger. The sterile Immucise Intradermal Injection Needle and Immucise Syringe are packed separately and assembled prior to use. The Immucise Intradermal Injection System is operated by a manual process.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
deltoid region
Indicated Patient Age Range
infants aged two months (excluding low birth weight and/or preterm birth) 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Test: Bench testing for Immucise Intradermal Injection System was performed in K181369 using non-aged and aged samples and met the predetermined acceptance criteria. No additional bench tests were deemed necessary to support the expanded indication, since the subject device is identical to the primary predicate K181369.
Animal Test: Terumo conducted an animal study to demonstrate the intended use of intradermal injection for adults in K181369. In order to expand the indications for use from adults only to infants (aged two months) to adults, Terumo conducted an additional animal study. The test method and acceptance criteria are same as the study performed previously except for the skin thickness.
- Test Name: Animal study (Functionality test). Test Description / Standard: In-house standard: This study was conducted to evaluate the efficacy of Immucise Intradermal Injection System for the indication for use. The test compared the post-injection wheal formation success rate between the Immucise Intradermal Injection System and the reference device of West Intradermal Adapter.
- Test Name: Animal study (Histopathological evaluation). Test Description / Standard: In-house standard: This study was conducted to validate the injection depth required for the indications for use.
Based on these animal studies, Terumo concludes that the Immucise Intradermal Injection System has been found to be substantially equivalent for the intended use and for the target patient population without raising different questions of safety and effectiveness. The test results support a determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 18, 2019
Terumo Corporation % Rudima Jackson Regulatory Affairs Specialist Terumo Medical Corporation 265 Davidson Ave Suite 320 Somerset, New Jersey 08873
Re: K190427
Trade/Device Name: Immucise Intradermal Injection System Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI, FMF Dated: June 19, 2019 Received: June 20, 2019
Dear Rudima Jackson:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Alan Stevens Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190427
Device Name
Immucise Intradermal Injection System
Indications for Use (Describe)
The Immucise Intradermal Injection System is injections of FDA approved drugs. The system is to be used in the deltoid region for infants aged two months (excluding low birth weight and/or preterm birth) to adults.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(K) Summary: K190427
| Manufacturer: | Kofu Factory of Terumo Corporation (510(k) applicant)
Registration Number: 9681835 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------|
| Address: | 1727-1 Tsuijiarai, Showa-Cho
Nakakoma-Gun, Yamanashi, Japan 409-3853 |
| Corresponding official: | Rudima L Jackson
Regulatory Affairs Specialist
Terumo Medical Corporation |
| Telephone Number:
Email: | (732)302-4900
rudima.jackson@terumomedical.com |
| Summary Date: | July 8, 2019 |
| Trade Name: | Immucise Intradermal Injection System |
| Common or Usual Name: | Intradermal Needle and Syringe |
| Regulation Number: | 21 CFR 880.5570 |
| Regulation Name: | Hypodermic Single Lumen Needle |
| Product Code: | FMI (Needle) and FMF (Syringe) |
| Class: | II |
| Panel: | General Hospital |
| Primary Predicate Device: | Immucise Intradermal Injection System, Manufactured by
Kofu Factory of Terumo Corporation (Japan)
(K181369) |
| Reference Device: | Intradermal Adapter, Manufactured by West
Pharmaceutical Services, Inc.
(K123588) |
Device Description:
The Immucise Intradermal Injection System is a single use, electron beam radiation sterilized device that is designed to be used for intradermal injections of FDA approved drugs. This system consists of an Intradermal Injection Needle and an Immucise Syringe. The system is made of common materials used in needles and syringes. The Immucise Intradermal Injection Needle is comprised of a needle base. The Immucise Syringe is comprised of a barrel, a gasket and a plunger. The sterile Immucise Intradermal Injection Needle and Immucise Syringe are packed separately and assembled prior to use. The Immucise Intradermal Injection System is operated by a manual process.
4
Indications for Use:
The Immucise Intradermal Injection System is indicated for intradermal injections of FDA approved drugs. The system is to be used in the deltoid region for infants aged two months (excluding low birth weight and/or preterm birth) to adults.
Technological Characteristics:
The Immucise Intradermal Injection System with the pediatric indication is the same as its primary predicate device, K181369. The only change is the expanded indication to include infants aged two months (excluding low birth weight and/or preterm birth) to adults. Therefore, all technological characteristics are the exact same.
Summary of Comparative Information
This traditional 510(k) is being submitted for the Immucise Intradermal Injection System with the intent of expanding the indication to include infants aged two months (excluding low birth weight and/or preterm birth) to adults. The subject device is the same device as the primary predicate cleared under K181369 except for the Indications for Use. It has the same intended use, operating principle, design, construction, materials, and sterilization method. The proposed device also has the same design specification to the needle gauge, needle length, and syringe nominal capacity.
| Feature of the
device | Subject Device
Immucise
Intradermal
Injection System | Primary Predicate
(K181369)
Immucise
Intradermal
Injection System | Reference Device
(K123588)
Intradermal
Adapter | Discussion /
Comment to
Primary
Predicate |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | FMI, FMF | FMI, FMF | FMF | Same as
K181369 |
| Classification | II | II | II | Same as
K181369 |
| Number of
uses | Single use Rx only | Single use Rx only | Single use Rx only | Same as
K181369 |
| Materials | The subject device is
constructed of
materials commonly
used in medical
devices.
Needle
• Needle Tube
• Stainless steel
cannula*
• Silicone oil lubricant*
• Needle base
• Polypropylene hub* | The subject device is
constructed of
materials commonly
used in medical
devices.
Needle
• Needle Tube
• Stainless steel
cannula*
• Silicone oil lubricant*
• Needle base
• Polypropylene hub* | The West
Pharmaceutical
device is
constructed of
materials
commonly used in
medical devices.
Adapter
• Polycarbonate | Same as
K181369 |
| | • Polypropylene luer
lock connector*
• Styrene-based TPE w/
pigment elastic spacer*
• Polyacrylate needle
hub adhesive
Syringe
• Barrel
• Polypropylene barrel*
• Silicone oil lubricant*
• Black ink barrel
printing
• Gasket
• Styrene-based TPE w/
pigment*
• Silicone oil lubricant*
• Plunger
• Polystyrene
Patient body
contacting material | • Polypropylene luer
lock connector
• Styrene-based TPE w/
pigment elastic spacer*
• Polyacrylate needle
hub adhesive
Syringe
• Barrel
• Polypropylene barrel*
• Silicone oil lubricant*
• Black ink barrel
printing
• Gasket
• Styrene-based TPE w/
pigment*
• Silicone oil lubricant*
• Plunger
• Polystyrene
*Patient body
contacting material | | |
| Sterilization
method | Electron Beam
radiation | Electron Beam
radiation | Ethylene Oxide | Same as
K181369 |
| Biocompatibility | Biocompatible
The finished device's
patient contacting
parts were assessed in
accordance with tests
recommended in the
FDA Guidance - Use
of International
Standard ISO-10993-
1, "Biological
evaluation of medical
devices - Part 1:
Evaluation and testing
within a risk
management
process." | Biocompatible
The finished device's
patient contacting
parts were assessed in
accordance with tests
recommended in the
FDA Guidance - Use
of International
Standard ISO-10993-
1, "Biological
evaluation of medical
devices - Part 1:
Evaluation and testing
within a risk
management
process." | Information not
available | Same as
K181369 |
| Indications for
Use | The Immucise
Intradermal Injection
System is indicated
for use in intradermal
injections of FDA
approved drugs.
The system is to be
used in the deltoid
region for infants
aged two months
(excluding low birth
weight and/or
preterm birth) to
adults | The Immucise
Intradermal Injection
System is indicated
for use in intradermal
injections of FDA
approved drugs.
The system is to be
used in the deltoid
region for adults. | 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 proposed
indications for
use for the
subject device
have been
modified to
include a
specific user
population
(pediatric) to
the primary
predicate. The
differences in
the indications |
| | | | | |
| Operating
principles | Manual | Manual | Manual | a new intended
use. As the
intended use in
the subject and
predicate
devices has not
changed, the
modification to
the indications
for use does not
raise different
questions of
safety and
effectiveness. |
| | | | | Same as
K181369 |
| Design
specifications | Needle Gauge
33G (0.2 mm)
Needle Length
1.15 mm
Syringe Nominal
Capacity
0.4 mL | Needle Gauge
33G (0.2 mm)
Needle Length
1.15 mm
Syringe Nominal
Capacity
0.4 mL | Adapter
Designed to adapt
to a disposable 1cc
piston syringe with
needle (1 ml of
capacity, 1/2"
needle length, 27 –
29G needle gauge). | Same as
K181369 |
| Package
(Primary) | Needle
Individual package
Syringe
Blister package | Needle
Individual package
Syringe
Blister package | Adapter
Blister package | Same as
K181369 |
| Shelf life | Needle: 36 months
Syringe: 12 months | Needle: 36 months
Syringe: 12 months | Information not
available | Same as
K181369 |
Summary of comparative information
5
6
Performance Data:
Bench Test
Bench testing for Immucise Intradermal Injection System was performed in K181369 using non-aged and aged samples and met the predetermined acceptance criteria. No additional bench tests were deemed necessary to support the expanded indication, since the subject device is identical to the primary predicate K181369.
Animal Test
Terumo conducted an animal study to demonstrate the intended use of intradermal injection for adults in K181369. In order to expand the indications for use from adults only to infants (aged two months) to adults, Terumo conducted an additional animal study. The test method and acceptance criteria are same as the study performed previously except for the skin thickness.
7
| Test Name | Test Description / Standard |
|---|---|
| Animal study | |
| (Functionality test) | In-house standard: This study was conducted to evaluate |
| the efficacy of Immucise Intradermal Injection System for | |
| the indication for use. The test compared the post-injection | |
| wheal formation success rate between the Immucise | |
| Intradermal Injection System and the reference device of | |
| West Intradermal Adapter. | |
| Animal study | |
| (Histopathological | |
| evaluation) | In-house standard: This study was conducted to validate |
| the injection depth required for the indications for use. |
Based on these animal studies, Terumo concludes that the Immucise Intradermal Injection System has been found to be substantially equivalent for the intended use and for the target patient population without raising different questions of safety and effectiveness. The test results support a determination of substantial equivalence.
Conclusion:
In summary, the intended use, technology/principle of operation, materials, and performance showed that the subject device did not raise different questions of safety and effectiveness when compared to the predicate devices. Therefore, Immucise Intradermal Injection System is substantially equivalent to the legally marketed Predicate Device.