(80 days)
Not Found
Not Found
No
The device description and performance studies focus on mechanical properties and volume delivery accuracy, with no mention of AI or ML.
No.
The device is described as an accessory for a prefilled syringe, designed to aid in the accurate delivery of a prescribed volume of medication, not to directly treat or diagnose a disease or condition.
No
Explanation: The device is a 'Clip-On Spacer' designed to help administer a specific volume of medication from a pre-filled syringe. Its function is to limit the volume of solution delivered, not to diagnose a condition or disease.
No
The device description clearly states it is a physical "Clip-On Spacer" that clips around a syringe plunger rod and is held in place with a hook-hole closure. This describes a hardware component, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The Clip-On Spacer is described as a mechanical accessory designed to limit the volume of medication delivered from a pre-filled syringe. It physically interacts with the syringe plunger rod.
- Lack of Diagnostic Testing: The description focuses on the mechanical function of controlling volume delivery and does not mention any testing of biological samples or providing diagnostic information.
The device is a delivery aid for a therapeutic product, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The Clip-On Spacer is intended only for use with pre-filled syringes containing 22 mcg/0.5 mL or 44 mcg/0.5 mL of Rebit®, during the titration stage of treatment. The spacer clips onto the plunger of the syringe so that the distance which the plunger inserts into the barrel when depressed is controlled.
Instructions for use are provided with the Rebit® pre-filled syringe for manual titration with the syringe. These instructions cover all aspects of the treatment regime and are not affected by use of the Clip-On Spacer. The Clip-On Spacer is simply an accessory provided to assist the user in injecting a portion of the Rebit® pre-filled syringe. The use of the Clip-On Spacer during injection of Rebit® in no way affects the treatment regime approved by FDA under BLA STN BL 103780/0.
The Clip-On Spacer is designed for use with Rebit® prefilled syringes containing The Clip-On Spacer is designed for use with Rebile pro mode of may and therapy.
The Clip-On Spacer is designed to aid the user in injecting the appropriate The Clip-On Spacer Is designed to "Blu" the "Boo" in "Myoung" when less than the full volume of the syringe is prescribed.
Product codes (comma separated list FDA assigned to the subject device)
FMF
Device Description
The Clip-On Spacer is designed to clip around the plunger rod of the Rebit® pre-filled syringe. It is held in place using a hook-hole closure which resists opening, once closed, under axial compression of 28N. When the plunger rod is depressed into the syringe barrel, the Clip-On Spacer limits the volume of solution delivered from the syringe to within ± 1.5% of the syringe volume (1 mL) ± 2% of the expelled volume according to EN ISO 7886-1:1997 "Sterile hypodermic syringes for single use -- Part 1: Syringes for manual use"..
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
Not Found
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)
The Clip-On Spacer has been tested for volume delivery accuracy, force and drop testing and risk analysis. The accuracy of volume delivered was within ±1.5% of the syringe volume (1 mL) and ±2% of the expelled volume in accordance with EN ISO 7886-1;1997. The Clip-On Spacer is able to bear axial compression of 28N (14N x 2) without deforming or opening the hook-hole closure. The rigidity of the Clip-On Spacer and the sturdiness of the closing system are strong enough to take a fall of 1 meter on a hard ground without any impact on the safety of the closing system. The results of a risk analysis performed according to ISO/EN 1441 indicated that there is no risk inherent in using the Clip-On Spacer and there are no additional hazards induced with the injection of Rebit® with the spacers compared to manual titration.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The accuracy of volume delivered was within ±1.5% of the syringe volume (1 mL) and ±2% of the expelled volume.
The Clip-On Spacer is able to bear axial compression of 28N (14N x 2).
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.
Not Found
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 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
JUL 1 5 2004
Exhibit I
510(k) Summary Rebif® Clip-On Spacer
Serono, Inc. One Technology Place Rockland, MA 02370
- Contact Person:
Pamela Williamson Joyce Phone: 781-681-2298 Fax: 781-681-2924 e-mail: pamela.williamson@serono.com
-
- Date Summary Prepared: April 2, 2004
-
- Device Information:
| Proprietary Name: | Clip-On Spacer |
|---|---|
| Common Name: | Manual Titration Clip for Piston Syring |
| Classification Name: | Syringe, Piston |
| Regulatory Class: | Class II by 21 CFR §880.5860 |
| Product Code: | FMF |
4. Device Description and Performance:
The Clip-On Spacer is designed to clip around the plunger rod of the Rebit® pre-filled syringe. It is held in place using a hook-hole closure which resists opening, once closed, under axial compression of 28N. When the plunger rod is depressed into the syringe barrel, the Clip-On Spacer limits the volume of solution delivered from the syringe to within ± 1.5% of the syringe volume (1 mL) ± 2% of the expelled volume according to EN ISO 7886-1:1997 "Sterile hypodermic syringes for single use -- Part 1: Syringes for manual use"..
5. Substantial Equivalence:
The substantial equivalence of the Clip-On Spacer for injection of solution from prefilled Rebif® syringes to manual titration is shown by its similarity intended use, design, materials, and performance characteristics.
1
6. Indications for Use:
The Clip-On Spacer is intended only for use with pre-filled syringes containing 22 mcg/0.5 mL or 44 mcg/0.5 mL of Rebit®, during the titration stage of treatment. The spacer clips onto the plunger of the syringe so that the distance which the plunger inserts into the barrel when depressed is controlled.
Instructions for use are provided with the Rebit® pre-filled syringe for manual titration with the syringe. These instructions cover all aspects of the treatment regime and are not affected by use of the Clip-On Spacer. The Clip-On Spacer is simply an accessory provided to assist the user in injecting a portion of the Rebit® pre-filled syringe. The use of the Clip-On Spacer during injection of Rebit® in no way affects the treatment regime approved by FDA under BLA STN BL 103780/0.
7. Comparison:
The features of the Clip-On Spacer used during injection of solution from a pre-filled Rebif® syringe versus manual injection are compared in the following Table 2:
| | Manual injection of
Rebif® from Pre-filled
Syringes using the
Clip-On Spacer | injection of Rebif®
with Rebiject IITM
device from Pre-
filled Syringes using
the Clip-On Spacer | Manual
Injection of
Rebif® from
Pre-filled
Syringes |
|------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| DESIGN | | | |
| Solution provided in syringe
exceeds required volume for
titration phase | Yes | Yes | Yes |
| User depresses plunger rod
to calibration appropriate
mark on syringe barrel | No (Clip-On Spacer
stops the plunger
rod at the correct
titration volume) | No (Clip-On Spacer
stops the plunger
rod at the correct
titration volume) | Yes (visually) |
| Plunger rod is limited to pre-
determined depth within
syringe barrel | Yes | Yes | No |
| INTENDED USE | | | |
| Facilitate injection of less
than the full volume of a pre-
filled syringe | Yes | Yes | Yes |
| MATERIALS | | | |
| Appropriate materials for
degree of patient contact | Yes | Yes | Yes |
Table 2. Comparison of Rebif Clip-On Spacer to Manual Injection using Rebif Pre-filled Syringe
2
8. Non-clinical Performance Data:
The Clip-On Spacer has been tested for volume delivery accuracy, force and drop testing and risk analysis. The accuracy of volume delivered was within ±1.5% of the syringe volume (1 mL) and ±2% of the expelled volume in accordance with EN ISO 7886-1;1997. The Clip-On Spacer is able to bear axial compression of 28N (14N x 2) without deforming or opening the hook-hole closure. The rigidity of the Clip-On Spacer and the sturdiness of the closing system are strong enough to take a fall of 1 meter on a hard ground without any impact on the safety of the closing system. The results of a risk analysis performed according to ISO/EN 1441 indicated that there is no risk inherent in using the Clip-On Spacer and there are no additional hazards induced with the injection of Rebit® with the spacers compared to manual titration.
9. Clinical Performance Data:
None presented at this time.
10. Conclusion:
The Clip-On Spacer is an accessory provided to assist the user in injecting a portion of the Rebit® pre-filled syringe according to the treatment regime. The Clip-On Spacers an currately deliver the titrated dose required. The use of the Clip-On Spacer during injection of Rebit® in no way affects the treatment regime approved by FDA under BLA STN BL 103780/02
11. Additional Information:
None requested at this time.
3
Image /page/3/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the department's logo in the center. The logo consists of three stylized human figures in profile, arranged in a stacked formation. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 5 2004
Ms. Pamela Williamson Joyce, RAC Vice President, Regulatory Affairs & Quality Assurance, US Serono. Incorporated One Technology Place Rockland, Massachusetts 02370
Re: K041084 Trade/Device Name: Clip-on Spacer Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: April 23, 2004 Received: April 26, 2004
Dear Ms. Williamson Joyce:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
4
Page 2 -- Ms. Williamson Joyce
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours,
SuperKurnes
Olivia Liu, Ph.D.
fo
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K041084
Device Name: Clip-on Spacer
Indications for Use:
The Clip-On Spacer is designed for use with Rebit® prefilled syringes containing The Clip-On Spacer is designed for use with Rebile pro mode of may and therapy.
The Clip-On Spacer is designed to aid the user in injecting the appropriate The Clip-On Spacer Is designed to "Blu" the "Boo" in "Myoung" when less than the full volume of the syringe is prescribed.
Over-The-Counter Use Prescription Usc X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cly D. m
esthesiok
510(k) Number: K$\phi$41684
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