(50 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical function of a lockable enclosure for a syringe pump, with no mention of AI or ML technologies.
No.
The Lockbox is an accessory to a syringe pump, designed to secure the medication syringe, not to deliver therapy itself.
No
The provided text describes a Lockbox, an accessory to a syringe pump, intended to secure a medication syringe. It does not perform any diagnostic function.
No
The device is described as a "lockable, plastic enclosure" and an "accessory" to a syringe pump, indicating it 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 "hold a Medfusion™ 3000 Series Syringe Pump and provide reasonably secure access to the medication syringe contained within." This describes a physical enclosure for a medical device, not a device used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description: The description reinforces that it's a "lockable, plastic enclosure" for a syringe pump.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, calibrators, controls, or any other elements typically associated with IVD devices.
- Performance Studies: The performance studies focus on physical properties, usability, and biocompatibility, which are relevant to a medical device accessory but not to the analytical performance of an IVD.
Therefore, the Lockbox is an accessory for a medical device (a syringe pump) and does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
"The Lockbox is intended to hold a Medfusion™ 3000 Series Pump and provide reasonably secure access to the medication syringe contained within."
Product codes (comma separated list FDA assigned to the subject device)
MRZ
Device Description
The Lockbox is an accessory to the Medfusion™ 3000 Series Syringe Pump. It is a lockable, plastic enclosure for the pump when the pump is loaded with a commercially available syringe containing medication. The Lockbox may be attached to an IV pole with the Pole Mount Bracket or with modification to a horizontal square rail.
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 non-clinical testing included assessment of the physical properties of the Lockbox and its ability to achieve its intended use. Bench testing of the Lockbox confirmed the suitability of the device for its intended use. The following physical tests were performed: Bench Testing Usability Studies. A biocompatibility assessment of the device was also performed. The purpose of the biocompatibility assessment was to ensure that biocompatibility had been established for the device. The device is biocompatible based on the similarity of the materials of construction to other devices currently marketed by Smiths Medical MD, Inc. Human clinical studies were deemed not necessary to evaluate the safety or effectiveness of the Lockbox.
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
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).
0
510(k) Summary (As required by 21 CFR 807.92(c))
K091181 510(k) Number: Page 1 of 2
Date Prepared 20 April 2009, Updated 11 June, 2009
Submitter Information
JUN 1 2 2009
| Submitter's Name: | Smiths Medical MD, Inc. |
|---|---|
| Address: | 1265 Grey Fox Road |
| St. Paul, MN 55112 |
Establishment Registration: 2183502
Contact Person: James Chapman Sr. Regulatory Affairs Associate Phone: (651) 628-7611 Fax: (651) 628-7457
Device Information
| Trade Name: | Lockbox |
|---|---|
| Common Name: | Lockbox for use with Medfusion™ 3000 Series Pumps |
| Classification Name: | |
| Product Code: | MRZ |
| Regulation: | 21 CFR §880.5725 |
Predicate Device(s)
The predicate devices are the currently marketed LockBox for use with the CADD®-Solis Ambulatory Infusion Pump (K080743) and LockBox with Syringe Holder (K942161).
Device Description
The Lockbox is an accessory to the Medfusion™ 3000 Series Syringe Pump. It is a lockable, plastic enclosure for the pump when the pump is loaded with a commercially available syringe containing medication. The Lockbox may be attached to an IV pole with the Pole Mount Bracket or with modification to a horizontal square rail.
Intended Use/Indications for Use
The Lockbox is intended to hold a Medfusion™ 3000 Series Syringe Pump and provide reasonably secure access to the medication syringe contained within.
Lockbox for use with Medfusion™ 3000 Series Pumps Smiths Medical MD, Inc.
Smiths Medical MD, Inc. Submission Page 15
1
510(k) Summary Page 2 of 2
Summary of Non-Clinical Testing
The non-clinical testing included assessment of the physical properties of the Lockbox and its ability to achieve its intended use. Bench testing of the Lockbox confirmed the suitability of the device for its intended use. The following physical tests were performed:
Bench Testing Usability Studies
A biocompatibility assessment of the device was also performed. The purpose of the biocompatibility assessment was to ensure that biocompatibility had been established for the device. The device is biocompatible based on the similarity of the materials of construction to other devices currently marketed by Smiths Medical MD, Inc.
Summary of Clinical Testing
Human clinical studies were deemed not necessary to evaluate the safety or effectiveness of the Lockbox.
Statement of Equivalence
The Lockbox for Medfusion™ 3000 Series Pumps is substantially equivalent to the currently marketed LockBox for use with the CADD® -Solis Ambulatory Infusion Pump and LockBox with Syringe Holder based on a comparison of the indications for use and the technological characteristics of the device.
Conclusion
The Lockbox for use with Medfusion™ 3000 Series Pumps is substantially equivalent to the currently marketed LockBox for use with the CADD -Solis Ambulatory Infusion Pump and LockBox with Syringe Holder based on the technological characteristics of the devices. Bench tests confirmed the suitability of the device for its intended use.
Lockbox for use with Medfusion™ 3000 Series Pumps Smiths Medical MD, Inc.
Smiths Medical MD, Inc. Submission Page 16
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 with three stripes forming its body and wing. The eagle faces to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Public Health Service
JUN 1 2 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. James Chapman Senior Regulatory Affairs Associate Smiths Medical MD, Incorporated 1265 Grey Fox Road Sait Paul, Minnesota 55112
Re: K091181
Trade/Device Name: Lockbox for Medfusion™ 3000 Series Pumps Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MRZ Dated: April 20, 2009 Received: April 23, 2009
Dear Mr. Chapman:
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 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- Mr. Chapman
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 (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 go to http://www.fda.gov/AboutFDA/Centers Offices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrh/mdr/ 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 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,
Susan Runner
Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
4
SMITHS MEDICAL MD, INC. 510(k) Premarket Notification
Indications for Use Statement
Koqußi 510(k) Number: __
Device Name: Lockbox for Medfusion™ 3000 Series Pumps
Indications for Use:
"The Lockbox is intended to hold a Medfusion™ 3000 Series Pump and provide reasonably secure access to the medication syringe contained within."
Prescription Use ਮ (Per 21 CFR 801 . 109)
AND/OR
Over-The Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sef. R.R.
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K091181
Lockbox for use with Medfusion™ 3000 Series Pumps Submission Page 14
Tab 5 - 1