(245 days)
Not Found
No
The device description and performance studies focus on the mechanical and physical properties of a standard syringe and needle, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is a syringe, which is used to administer a drug (GONAL-f Multi-Dose). The syringe itself does not provide a therapeutic effect; it is a delivery mechanism for a therapeutic agent.
No
The device is a hypodermic syringe for manual aspiration and injection of medication, not for diagnosing medical conditions.
No
The device description clearly states it is comprised of a standard piston syringe with a permanently attached needle, which are physical hardware components. The performance studies also focus on physical characteristics and functionality of the syringe and needle.
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 manual aspiration and injection of a drug (GONAL-f Multi-Dose) into the body. This is a drug delivery device, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details a standard syringe and needle, designed for injecting substances.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any process related to in vitro testing.
- Performance Studies: The performance studies focus on the physical and functional characteristics of the syringe and needle (cleanliness, leakage, mobility, etc.), which are typical for drug delivery devices, not IVDs.
Therefore, this device falls under the category of a drug delivery device or medical device for injection, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The "Syringe with fixed needle - For use only with GONAL-f Multi-Dose 600 IU/mL FSH" is a hypodermic syringe with fixed needle intended for manual aspiration of GONAL-f Multi-Dose and for the solution into parts of the body below the surface of the skin.
The syringes designed for manual use are intended for use soon after filling, as they are not suitable for containing GONAL-f Multi-Dose over extended periods of time.
Product codes
FMF,FMI
Device Description
The "Syringe with fixed needle – For use only with GONAL-f Multi-Dose 600 IU/mL FSH" is comprised of a standard piston syringe with a permanently attached (fixed) hypodermic single lumen needle designed for the manual aspiration and injection of GONAL-f Multi-Dose. The needle is covered by a protective cap. The graduated scale is specifically designed for GONAL-f Multi-Dose. This syringe is a 1 ml syringe with 27G x 12" fixed needle. This is a single use syringe.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Body parts below the surface of the skin.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
All necessary verification and validation tests have been performed by testing the "Syringe with fixed needle - For use only with GONAL-f Multi-Dose 600 IU/mL FSH". Summary of the verification activities including acceptance criteria is given in the table below:
| TEST | STANDARD OR INTERNAL ACCEPTANCE CRITERIA |
|---|---|
| 1. Cleanliness and visual appearance | Cleanliness and visual appearance in accordance with EN ISO 8537. |
| 2. Position of gasket | The gasket is assembled so that the fiducial line is positioned at 3 mm +1/-3 mm from the zero-line of the graduation in accordance with internal acceptance criteria. |
| 3. Effective needle length | Effective needle length needs to be between 10 and 14 mm in accordance with internal acceptance criteria. |
| 4. Blister dimension + seal width | The dimension of the blister pack is in accordance with the technical drawing (LxW: 150 x 34.3 mm). The seal width of the blister pack is minimum 2 mm. This is in accordance with internal acceptance criteria. |
| 5. Peel behavior | Peel behavior in accordance with EN ISO 11607-1. |
| 6. Sterile barrier system integrity | Sterile barrier system integrity in accordance with EN ISO 11607-1. |
| 7. Peel strength | Peel strength in accordance with EN ISO 11607-1. |
| 8. Seal strength | Seal strength in accordance with EN ISO 11607-1. |
| 9. Package burst | Package burst test in accordance with EN ISO 11607-1. |
| 10. Air leakage past gasket and needle/barrel connection | No leakage of air past the gasket and needle/barrel connection in accordance with EN ISO 8537. |
| 11. Liquid leakage past gasket and needle/barrel connection | No leakage of water past the gasket and needle/barrel connection in accordance with EN ISO 8537. |
| 12. Mobility Force | The Initial Force is maximum 10 N and the Emptying Force is maximum 1.0 N in accordance with internal acceptance criteria. |
| 13. Tolerance on graduated capacity | Tolerance on graduated capacity is in accordance with EN ISO 8537 |
| 14. Dead space volume | Dead space volume in accordance with EN ISO 8537. |
| 15. Plunger-gasket assembly fitting | The gasket-plunger does not separate in accordance with internal acceptance criteria. |
| 16. Stopper function strength | The stopper function strength is more than 10 N in accordance with internal acceptance criteria. |
| 17. Barrel printing resistance | To check the readability of the graduated printing of syringes after contact with water, ethanol, oil, antiseptic solution or tension-active solution, or after pencil scratching or dry rubbing with finger. This is in accordance with internal acceptance criteria. |
| 18. Protector fitting strength | The protector fitting strength is between 2 N and 12 N in accordance with internal acceptance criteria. |
| 19. Bonding strength cannula | Bonding strength of the cannula in accordance with EN ISO 8537. |
| 20. Needle penetration resistance | The penetration resistance of cannula point and drag complies with the limits specified as follow: Point Value ≤ 0.12 N and Drag Value ≤ 0.04 N. This is in accordance with internal acceptance criteria. |
| 21. Transport simulation test | There is no damage of the sterile barrier after vibration test (in accordance with EN ISO 2247), roll test (in accordance with EN ISO 2876) and vertical impact test (in accordance with drop test) (in accordance with EN ISO 2248) |
The sterility of the "Syringe with fixed needle – For use only with GONAL-f Multi-Dose 600 IU/mL FSH" is assured by using a validated sterilization method qualified in accordance with EN ISO 11135: "Sterilization of health care products - Ethylene oxide: Requirements for development, validation and routine control of a sterilization process for medical devices" to a sterility assurance level (SAL) of 10-6.
Ethylene oxide and ethylene chlorohydrin residual levels resulting from EtO sterilization are in compliance with EN ISO 10993-7: "Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals". The shelf life has been established at 5 years.
The "Syringe with fixed needle – For use only with GONAL-f Multi-Dose 600 IU/mL FSH" is an External Communicating device, Contacting Circulating Blood, Limited Exposure (≤ 24 hrs). The device's blood contacting materials were tested in accordance with the tests recommended in the FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard EN ISO-10993-1, "Biological Evaluation of Medical Devices. Part-1: Evaluating and testing within a risk management process". The following biocompatibility tests have been performed:
- cytotoxicity (in accordance with EN ISO 10993-5),
- haemolysis (in accordance with EN ISO 10993-4),
- systemic (acute) toxicity (in accordance with EN ISO 10993-11),
- intracutaneous reactivity (in accordance with EN ISO 10993-10),
- sensitization (in accordance with EN ISO 10993-10),
- pyrogenicity
- LAL Testing
Results of the testing demonstrate that the blood contacting materials are biocompatible.
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.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird in flight, composed of three human profiles facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 10, 2017
Terumo Europe N.V. Mrs. M.J. Aerts Regulatory Affairs Manager Interleuvenlaan 40 3001 Leuven BELGIUM
Re: K161606
Trade/Device Name: Syringe with fixed needle - For use only with GONAL-f Multi-Dose 600IU/mL FSH Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF,FMI Dated: December 22, 2016 Received: January 11, 2017
Dear Mrs. M.J. Aerts:
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 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 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/Resourcesfor You/Industry/default.htm. 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 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,
Image /page/1/Picture/8 description: The image contains a signature of Tina Kiang. The signature is written in black ink and is on a white background. The signature is illegible, but the name Tina Kiang is clearly visible.
Tina Kiang, Ph.D. Acting 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) K161606
Device Name
Syringe with fixed needle - For use only with GONAL-f Multi-Dose 600 IU/mL FSH
Indications for Use (Describe)
The "Syringe with fixed needle - For use only with GONAL-f Multi-Dose 600 IU/mL FSH" is a hypodermic syringe with fixed needle intended for manual aspiration of GONAL-f Multi-Dose and for the solution into parts of the body below the surface of the skin.
The syringes designed for manual use are intended for use soon after filling, as they are not suitable for containing GONAL-f Multi-Dose over extended periods of time.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
ll. 510(k) SUMMARY as required by 807.92 (K161606)
Submitter Information
| Prepared for: | TERUMO EUROPE N.V.
Interleuvenlaan 40,
3001 Leuven,
BELGIUM |
|----------------|-------------------------------------------------------------------------------------------------|
| Prepared by: | Mrs. M.J. Aerts - Manager Regulatory Affairs
Tel. (+32) 16 38 13 53
Fax (+32) 16 40 02 49 |
| Date prepared: | February 9, 2017 |
II.1. Device Name
Proprietary Name: Syringe with fixed needle - For use only with GONAL-f Multi-Dose 600 IU/mL FSH
Common Name: Hypodermic syringe with a fixed hypodermic single lumen needle
Regulation Name: Piston syringe
Regulation Number: 880.5860
Product Code: FMF,FMI
Review Panel: General Hospital
Classification: Class II
II.2. Predicate Device
Proprietary Name: Serono GONAL-f Multi-dose Use Only at 600IU/ml Syringe Regulation Name: Piston Syringe Requlation Number: 880.5860 Product Code: FMF Classification: Class II
II.3. Indications for Use
The "Syringe with fixed needle - For use only with GONAL-f Multi-Dose 600 IU/mL FSH" is a hypodermic syringe with fixed needle intended for manual aspiration of GONAL-f Multi-Dose and for injection of this solution into parts of the body below the surface of the skin.
The syringes designed for manual use are intended for use soon after filling, as they are not suitable for containing GONAL-f Multi-Dose over extended periods of time.
||.4. Description
The "Syringe with fixed needle – For use only with GONAL-f Multi-Dose 600 IU/mL FSH" is comprised of a standard piston syringe with a permanently attached (fixed) hypodermic single lumen needle designed for the manual aspiration and injection of GONAL-f Multi-Dose. The needle is covered by a protective cap. The graduated scale is specifically designed for GONAL-f Multi-Dose. This syringe is a 1 ml syringe with 27G x 12" fixed needle. This is a single use syringe.
4
II.5. Substantial Equivalence
| | Syringe with fixed needle - For use only
with GONAL-f Multi-Dose 600 IU/mL FSH
(Terumo Europe, Belgium)
(Subject of this 510k) | Syringe - Use only with GONAL-f Multi-
dose at 600IU/ml
(Terumo Medical Corporation)
(K003571)
(Predicate device) |
|-----------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The "Syringe with fixed needle - For use
only with GONAL-f Multi-Dose 600 IU/mL
FSH" is a hypodermic syringe with fixed
needle intended for manual aspiration of
GONAL-F Multi-Dose and for the injection
of this solution into parts of the body
below the surface of the skin.
The syringes designed for manual use
are intended for use soon after filling, as
they are not suitable for containing
GONAL-f Multi-Dose over extended
periods of time | The Serono Gonal-f Multi-dose only at
600IU/ml syringe is intended for manual
aspiration of Gonal-f Multi-dose only at 600
IU/ml and for the injection of this solution
into body parts below the surface of the
skin. The syringe is designed for manual
use. It is specifically indicated for the Gonal-
f Multidose only solutions manufactured by
Serono Lab. |
| Materials
Plunger
Cannula
Protector
Barrel
Gasket
Lubricant
Printing
Description
/Specifications | Polypropylene + Masterbatch White
Stainless steel
Polypropylene + Masterbatch White
Polypropylene
Thermoplastic elastomer
Silicone
Black ink
Same as predicate | Polystyrene
Stainless steel
HD-Polyethylene + Masterbatch White
Polypropylene
Thermoplastic elastomer
Silicone
Black ink
A standard piston syringe made of a plastic
barrel and plunger and a synthetic rubber
gasket. |
| Needle Gauge/length | Same as predicate | 27G x ½" |
| Principle of Operation | Same as predicate | Manually |
| Unit packaging | Same as predicate | Blister packaging |
| Sterilization | EtO to SAL 10-6 | Gamma irradiation to SAL 10-6 |
| Shelf life | Same as predicate | 5 years |
Most characteristics are similar or identical.
There are some minor differences in the indications for use. The language has been updated to clearly state how the device is to be used and to indicate that the device should not to be used for storage of GONAL-f. These updates do not change the intended use of the device.
There are some differences in materials for the plunger and the protector, however polypropylene used for the proposed device is a well-known polymer material for medical applications, as are polystyrene and polyethylene used for the predicate device. The sterilization method is different, however SAL 100 is guaranteed by both EtO for the proposed device and gamma irradiation for the predicate device.
The differences do not raise questions of safety and effectiveness
II.6. Summary of Verification Activities
All necessary verification and validation tests have been performed by testing the "Syringe with fixed needle - For use only with GONAL-f Multi-Dose 600 IU/mL FSH". Summary of the verification activities including acceptance criteria is given in the table below:
| TEST | STANDARD OR INTERNAL ACCEPTANCE CRITERIA |
|---|---|
| 1. Cleanliness and visual appearance | Cleanliness and visual appearance in accordance with EN ISO 8537. |
5
| 2. Position of gasket | The gasket is assembled so that the fiducial line is positioned at 3 mm
+1/-3 mm from the zero-line of the graduation in accordance with internal acceptance
criteria. |
|-------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 3. Effective needle length | Effective needle length needs to be between 10 and 14 mm in accordance with
internal acceptance criteria. |
| 4. Blister dimension +
seal width | The dimension of the blister pack is in accordance with the technical drawing (LxW:
150 x 34.3 mm). The seal width of the blister pack is minimum 2 mm. This is in
accordance with internal acceptance criteria. |
| 5. Peel behavior | Peel behavior in accordance with EN ISO 11607-1. |
| 6. Sterile barrier system
integrity | Sterile barrier system integrity in accordance with EN ISO 11607-1. |
| 7. Peel strength | Peel strength in accordance with EN ISO 11607-1. |
| 8. Seal strength | Seal strength in accordance with EN ISO 11607-1. |
| 9. Package burst | Package burst test in accordance with EN ISO 11607-1. |
| 10. Air leakage past
gasket and needle/barrel
connection | No leakage of air past the gasket and needle/barrel connection in accordance with
EN ISO 8537. |
| 11. Liquid leakage past
gasket and needle/barrel
connection | No leakage of water past the gasket and needle/barrel connection in accordance
with EN ISO 8537. |
| 12. Mobility Force | The Initial Force is maximum 10 N and the Emptying Force is maximum 1.0 N in
accordance with internal acceptance criteria. |
| 13. Tolerance on
graduated capacity | Tolerance on graduated capacity is in accordance with EN ISO 8537 |
| 14. Dead space volume | Dead space volume in accordance with EN ISO 8537. |
| 15. Plunger-gasket
assembly fitting | The gasket-plunger does not separate in accordance with internal acceptance
criteria. |
| 16. Stopper function
strength | The stopper function strength is more than 10 N in accordance with internal
acceptance criteria. |
| 17. Barrel printing
resistance | To check the readability of the graduated printing of syringes after contact with water,
ethanol, oil, antiseptic solution or tension-active solution, or after pencil scratching or
dry rubbing with finger. This is in accordance with internal acceptance criteria. |
| 18. Protector fitting
strength | The protector fitting strength is between 2 N and 12 N in accordance with internal
acceptance criteria. |
| 19. Bonding strength
cannula | Bonding strength of the cannula in accordance with EN ISO 8537. |
| 20. Needle penetration
resistance | The penetration resistance of cannula point and drag complies with the limits
specified as follow: Point Value ≤ 0.12 N and Drag Value ≤ 0.04 N.
This is in
accordance with internal acceptance criteria. |
| 21. Transport simulation
test | There is no damage of the sterile barrier after vibration test (in accordance with EN
ISO 2247), roll test (in accordance with EN ISO 2876) and vertical impact test (in
accordance with drop test) (in accordance with EN ISO 2248) |
II.7. Additional Information
The sterility of the "Syringe with fixed needle – For use only with GONAL-f Multi-Dose 600 IU/mL FSH" is assured by using a validated sterilization method qualified in accordance with EN ISO 11135: "Sterilization of health care products - Ethylene oxide: Requirements for development, validation and routine control of a sterilization process for medical devices" to a sterility assurance level (SAL) of 10-6
Ethylene oxide and ethylene chlorohydrin residual levels resulting from EtO sterilization are in compliance with EN ISO 10993-7: "Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals". The shelf life has been established at 5 years.
The "Syringe with fixed needle – For use only with GONAL-f Multi-Dose 600 IU/mL FSH" is an External Communicating device, Contacting Circulating Blood, Limited Exposure (≤ 24 hrs). The device's blood contacting materials were tested in accordance with the tests recommended in the FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard EN ISO-10993-1, "Biological Evaluation of Medical Devices. Part-1:
6
Evaluating and testing within a risk management process". The following biocompatibility tests have been performed:
- cytotoxicity (in accordance with EN ISO 10993-5), ●
- haemolysis (in accordance with EN ISO 10993-4), ●
- systemic (acute) toxicity (in accordance with EN ISO 10993-11), ●
- intracutaneous reactivity (in accordance with EN ISO 10993-10), .
- sensitization (in accordance with EN ISO 10993-10), .
- . pyrogenicity
- LAL Testing ●
Results of the testing demonstrate that the blood contacting materials are biocompatible.
II.8. Conclusion
In summary, the "Syringe with fixed needle – For use only with GONAL-f Multi-Dose 600 IU/mL FSH" is substantially equivalent in intended use, description/specifications, technology/principal of operation, materials, and performance to the following cleared device: "Serono GONAL-f Multi-dose Use Only at 6001U/ml Syringe", manufactured by Terumo Medical Corporation (K003517).