(53 days)
Not Found
No
The description focuses on a mechanical modification (combining cartridge and holder) and explicitly states "The operating principle remains the same." There are no mentions of AI, ML, image processing, or data analysis that would suggest AI/ML is incorporated.
No.
The device is a holder for syringe cartridges used in the withdrawal and administration of sterile materials, rather than a device that directly treats a medical condition or ailment.
No
The device description states it is a "Syringe Cartridge Holder" and is used for "withdrawal and administration of sterile materials." This indicates it is for delivering substances, not identifying diseases or conditions.
No
The device description clearly states it is a "Syringe Cartridge Holder," which is a physical hardware component. There is no mention of software as the primary or sole component of the device.
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 "withdrawal and administration of sterile materials under aseptic conditions." This describes a process performed on a patient or for preparing materials for administration to a patient.
- Device Description: The device is a "Syringe Cartridge Holder" and a modification to a "Carpuject® cartridge and holder." This is a physical device used in the process of administering substances, not for testing samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
The iSecure Syringe Cartridge Holder is intended for use in the withdrawal and administration of sterile materials under aseptic conditions in accordance with the best judgment of the physician.
Product codes (comma separated list FDA assigned to the subject device)
IQG, FMF
Device Description
The proposed change is to combine the Carpuject® cartridge and holder into one preassembled unit thereby eliminating the need for a separate holder. The operating principle remains the same. The modified syringe holder accessory can still be used with both empty and prefilled (not the subject of this 510(k) application) Carpuject® Syringe Cartridges. The proposed name for this modification is the iSecure Syringe Cartridge Holder.
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
physician
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)
Not Found
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 890.5050 Daily activity assist device.
(a)
Identification. A daily activity assist device is a modified adaptor or utensil (e.g., a dressing, grooming, recreational activity, transfer, eating, or homemaking aid) that is intended for medical purposes to assist a patient to perform a specific function.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. If the device is not labeled or otherwise represented as sterile, the device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, regarding general requirements concerning records and § 820.198, regarding complaint files.
0
KO63180
510(k) SUMMARY
| 1. | Submitted by: | Hospira, Inc.
D-389, Bldg. H2
275 N. Field Drive
Lake Forest, IL 60045
Attn: Diane Rennpferd | Phone: | (224) 212-5452
Fax: (224) 212-5401 | |
|----|--------------------------------------|----------------------------------------------------------------------------------------------------------------|--------|---------------------------------------|--------------|
| | | | | | DEC 1 1 2006 |
| 2. | Date Prepared: | October 18, 2006 | | | |
| 3. | Name/Classification
of Device: | Adaptor, holder, syringe
Class I, IQG, 21 CFR 890.5050
Syringe, Piston
Class II, FMF, 21 CFR 880.5860 | | | |
| | 4. Trade Name of
Proposed Device: | iSecure Syringe Cartridge Holder | | | |
Predicate Devices: 5.
| Device Name | 510(k) Number |
|---|---|
| Empty Sterile Carpuject® Cartridge | K820164 |
| Syringe holder Accessory |
Proposed Device Description: 6.
The proposed change is to combine the Carpuject® cartridge and holder into one preassembled unit thereby eliminating the need for a separate holder. The operating principle remains the same. The modified syringe holder accessory can still be used with both empty and prefilled (not the subject of this 510(k) application) Carpuject® Syringe Cartridges. The proposed name for this modification is the iSecure Syringe Cartridge Holder.
7. Statement of Intended Use:
The iSecure Syringe Cartridge Holder is intended for use in the withdrawal and administration of sterile materials under aseptic conditions in accordance with the best judgment of the physician.
Summary of Technological Characteristics of New Device Compared to Predicate 8. Devices
The iSecure Syringe Cartridge Holder as described in this submission is substantially equivalent to the predicate Empty Sterile Carpuject Syringe Holder Accessory with respect to the following characteristics:
- . Both devices are intended to be used with either empty or prefilled (not the subject of this submission) Carpuject cartridges
- The technology and operating principles are the same for both devices .
1
- The plunger rod for both devices is attached to the end of the syringe cartridge to . actuate an injection.
The claim for substantial equivalence is supported by the information provided in the 510(k) submission.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three overlapping, curved lines forming the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
ood and Drug Administration 200 Corporate Boulevard Rockville MD 20850
Ms. Diane Rennpferd Senior Associate, Global Regulatory Affairs Devices Hospira, Incorporated 275 North Field Drive Dept. 389, Bldg. H2 Lake forest, Illinois 60045
DEC 1 1 2006
Re: K063180
Trade/Device Name: iSecure Syringe Cartridge Holder Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF, IQG Dated: November 20, 2006 Received: November 21, 2006
Dear Ms. Rennpferd:
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.
3
Page 2 - Ms. Rennpferd
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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sudra y Michael MD.
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
4
Indications for Use
510(k) Number (if known)
Device Name: iSecure Syringe Cartridge Holder
Indications for Use:
The iSecure Syringe Cartridge Holder is intended for use in the withdrawal and administration of sterile materials under aseptic conditions in accordance with the best judgment of the physician.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
AQ lell fir An
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