(395 days)
Not Found
No
The description focuses on a battery-powered mechanical device with firmware for controlled fluid delivery, and there is no mention of AI, ML, or related concepts.
No
The device is used to assist in the delivery of saline to fill tissue expanders, which is a supportive function rather than a direct therapeutic intervention.
No
The device is intended to assist in the delivery of sterile saline to fill temporary, removable tissue expanders, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it includes a battery-powered controller, firmware, LED displays, an external pressure sensor, and is battery powered. It also mentions a syringe cradle and other physical components in a kit. This indicates it is a hardware device with integrated software/firmware, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to assist in the delivery of sterile saline into a surgically placed sub-dermal tissue expander. This is a therapeutic or procedural use, not a diagnostic one.
- Device Description: The device is a battery-operated controller that assists in the mechanical delivery of fluid. It does not perform any tests on biological samples to provide diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing information for the diagnosis of a disease or condition.
- Anatomical Site: The device is used on a surgically placed sub-dermal site, which is related to a medical procedure, not a diagnostic test.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is purely mechanical assistance in a medical procedure.
N/A
Intended Use / Indications for Use
The Marz Blossom Syringe Assist device is intended to be used to assist the clinician in the delivery of sterile saline to fill temporary, removable tissue expanders in accordance with the best judgment of the clinician. Specifically, the Marz Blossom Syringe Assist device is indicated for assisting the clinician in delivery of sterile saline into the surgically placed sub-dermal temporary, removable tissue expander.
Product codes
LCJ
Device Description
- The Marz controller is a battery operated device that is used to assist the clinician in delivering sterile saline into a surgically placed sub-dermal temporary, removable tissue expander. The Marz Blossom Syringe Assist device includes a battery powered controller to provide a regulated method for delivery of a specific volume of saline at a syringe. The Marz Medical Blossom Syringe Assist Device consists of a re-useable controller with an integrated syringe cradle for holding a 10cc syringe, firmware, LED displays, an external pressure sensor, and is battery powered by three 1.5V, AA batteries (LR6 designation).
- Supplied with the controller in a kit are the following components: Single use, sterile 10cc luer lock piston syringe, transfer set with proximal connection to the controller, and saline reservoir including distal connections to the inflation port of the expander, or via an infusion needle. All connections are luer lock compatible. The fluid path is clear that allows for visual inspection of the content.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sub-dermal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinician
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
The following tests were completed and reported results are summarized:
- Study Type: Firmware/Software Verification Test
- Sample Size: Units
- Key Results: The units were subjected to software verification testing under normal use and normal conditions, all units passed the testing.
- Study Type: Performance Verification Test
- Sample Size: Devices
- Key Results: The devices were subjected to delivery of saline in their typical operating modes and specifications. All units passed testing.
- Study Type: Packaging Test (ISTA 2A)
- Sample Size: Not specified
- Key Results: The device was subjected to std transit testing which included: Preconditioning, Compression, Shock/Drop, Vibration Testing. The device were not damaged and remained functional after testing. The unit passed.
- Study Type: Shelf Life Test (6 Month)
- Sample Size: Devices
- Key Results: The devices were subjected to accelerated aging at elevated temperatures to simulate 6 month shelf life. All units passed all testing.
- Study Type: Thumb Force Test
- Sample Size: Not specified
- Key Results: Pass, force applied during injection is substantially equivalent to manual approach (thumb pressure)
- Study Type: Comparative Product Analysis and System Forces and Pressures (Notebook Testing)
- Sample Size: Not specified
- Key Results: The Blossom Syringe Assist device requires less force & pressure to dispense fluid than the 60cc syringe, and its predicate, McGhan Tissue fill kit.
- Study Type: Fault Conditions Test
- Sample Size: Not specified
- Key Results: All fault conditions were verified, and the device responded as designed. The unit passed the verification testing.
- Study Type: EMC FCC Part 15 Subpart B
- Sample Size: Not specified
- Key Results: Pass
- Study Type: IEC 60601 Part 1: 1990, Amd A1:1993, A11: 1993, A12; 1993; A2: 1995 and A13: 1996
- Sample Size: Not specified
- Key Results: Pass
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
IV. 510(k) Summary
Marz Blossom Syringe Assist Device
Submitter/Sponsor's Name, Address, Telephone Number, Contact Person and Date Prepared
Marz Medical, Inc. 2500 Hospital Drive, Bldg 9 2500 Hospital Drive, Blug 9
Mountain View, CA 94040---------------------------------------------------------------------------------------------------------------------------・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
Contact Person: C/O Mary Pascual Gallup VP of Regulatory Affairs
Phone: 510-441-4017 (Direct Line) Fax: 510-487-1587
Date Prepared: 06/02/2013
Marz Blossom Syringe Assist device Name of Device:
Common or Usual Name: Tissue Expander Accessory (Syringe Assist, Accessory)
Classification Name
| Classification: | |
|---|---|
| Class: | |
| Classification Name: |
Jnclassified Jnclassified Tissue Expander Accessory
Predicate Device
The Marz Blossom Syringe Accessory System is substantially equivalent to its predicate McGhan Tissue expander Fill Kit (K853014) commercially available via the FDA 510(k) Pre-Market Notification with regards to intended use, design, materials and technology. The Marz Blossom Syringe Assist device does not raise new questions associated with safety and efficacy relative to such commercially available medical devices.
Indications for Use
The Marz Blossom Syringe Assist device is intended to be used to assist the clinician in the delivery of sterile saline to fill temporary, removable tissue expanders in accordance with the
JUL 1 0 2014
1
best judgment of the clinician. Specifically, the Marz Blossom Syringe Assist device is indicated for assisting the clinician in delivery of sterile saline into the surgically placed sub-dermal temporary, removable tissue expander.
Device Description
-
- The Marz controller is a battery operated device that is used to assist the clinician in delivering sterile saline into a surgically placed sub-dermal temporary, removable tissue expander. The Marz Blossom Syringe Assist device includes a battery powered controller to provide a regulated method for delivery of a specific volume of saline at a -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------svringe. The Marz Medical Blossom Svringe Assist Device consists of a re-useable controller with an integrated syringe cradle for holding a 10cc syringe, firmware, LED displays, an external pressure sensor, and is battery powered by three 1.5V, AA batteries (LR6 designation).
-
- Supplied with the controller in a kit are the following components: Single use, sterile 10cc luer lock piston syringe, transfer set with proximal connection to the controller, and saline reservoir including distal connections to the inflation port of the expander, or via an infusion needle. All connections are luer lock compatible. The fluid path is clear that allows for visual inspection of the content.
Technological Characteristics
The Marz controller is a battery operated device that is used to assist the clinician in delivering sterile saline into a surgically placed sub-dermal temporary, removable tissue expander. The Marz Blossom Syringe Assist device includes a battery powered controller to provide a requlated method for delivery of a specific volume of saline at a specific rate. The Marz controller is compatible with 10cc plastic luer lock piston barrel syringe. The Marz Medical Blossom Syringe Assist Device consists of a re-useable controller with an integrated syringe cradle for holding a 10cc syringe, firmware. LED displays, an external pressure sensor, and is battery powered by three 1.5V, AA batteries (LR6 designation).
The Marz Blossom Syringe Assist device controller has been evaluated for and has passed criteria for safety and performance testing. The Marz Blossom Syringe Assist device has also passed design verification and validation testing criteria in accordance with internal company controls and design control procedures to support the safety and intended use of the product.
2
Performance Testing Conducted
The following tests were completed and reported results are summarized.
| Reference No./Description | Report Title | Overall Results |
|---|---|---|
| MRZ-TR-881 - Verify | ||
| software will respond as | ||
| designed under normal | ||
| operating conditions. | Fluid Delivery System | |
| (FDS) Firmware/Software | ||
| Verification Test Report | The units were subjected to | |
| software verification testing | ||
| under normal use and | ||
| normal conditions, all units | ||
| passed the testing. | ||
| MRZ-TR-882 -- Verify the | ||
| device can deliver saline to | ||
| the tissue expander within | ||
| the parameters of the | ||
| specification. | Performance Verification | |
| Test Report | The devices were subjected | |
| to delivery of saline in their | ||
| typical operating modes | ||
| and specifications. All | ||
| units passed testing. | ||
| MRZ-TR-880 - Verify | ||
| packaging can withstand | ||
| shipping conditions without | ||
| damage or loss of function | ||
| to the device. This testing | ||
| included: | ||
| • Preconditioning. | ||
| • Compression | ||
| • Shock/Drop | ||
| • Vibration Testing | ||
| • Functional | ISTA 2A Packaging Test, | |
| Blossom System | The device was subjected | |
| to std transit testing which | ||
| included: | ||
| • Preconditioning. | ||
| • Compression | ||
| • Shock/Drop | ||
| • Vibration Testing. | ||
| The device were not | ||
| damaged and remained | ||
| functional after testing. The | ||
| unit passed. | ||
| MRZ-TR-886 - Verify | ||
| tubing set adaptor | ||
| accessory can be stored for | ||
| 6 months without loss of | ||
| sterility. | ||
| This testing included: | ||
| • Tensile Test of | ||
| pouch. | ||
| • Dye Penetration of | ||
| the pouch. | 6 Month Shelf Life | The devices were subjected |
| to accelerated aging at | ||
| elevated temperatures to | ||
| simulate 6 month shelf life. | ||
| All units passed all testing. | ||
| Reference No./Description | Report Title | Overall Results |
| Tensile Test of joints found in the accessory assemblies. MRZ-TR-883 -- The | ||
| purpose of this test was to | ||
| compare actual thumb | ||
| pressure to depress a 10ml | ||
| syringe vs. the force |
| Thumb Force Test Report | Pass, force applied during
injection is substantially
equivalent to manual
approach (thumb pressure) |
| generated by the
automated system to
depress a 10ml syringe. | | |
| Notebook Testing
The purpose of this test
was to quantify the
pressures the 10cc Luer
Lock syringe with automatic
spring return dispensing
system could generate by
depressing the plunger and
the forces required to
recycle the dispensing
system.
Additional tests were
conducted to determine
max force and pressure
generated by the Marz
device.
Lastly, Forces required to
depress the plunger and
max. pressure for 10cc and
60cc single piston syringe
without automatic return vs.
the Marz device. | Comparative Product
Analysis and System
Forces and Pressures | Summary: The Blossom
Syringe Assist device
requires less force &
pressure to dispense fluid
than the 60cc syringe, and
its predicate, McGhan
Tissue fill kit. |
| MRZ-TR-955 -- Verify that
the software fault | Marz Medical, Inc. Fluid
Delivery System Fault | All fault conditions were
verified, and the device |
| Reference No./Description | Report Title | Overall Results |
| conditions were verifiable
during testing. | conditions test Report. | responded as designed.
The unit passed the
verification testing. |
| EMC FCC Part 15 Subpart B | | Pass |
| IEC 60601 Part 1: 1990, Amd A1:1993, A11:
1993, A12; 1993; A2: 1995 and A13: 1996 | | Pass |
3
..............................................................................................................................................................................
Marz Medical, Inc. Blossom Delivery Assist Device K131692 510K Notification
4
Substantial Equivalence
The Marz Blossom Syringe Assist device has the same intended uses and similar indications. technological characteristics, and principles of operation as its predicate device The McGhan Tissue Fill Kit (K853014). Both systems have two, one-way valves that prevent backflow into the fluid source, which is the saline bag. After a specified volume is delivered, both devices have an automatic refill feature. The technological differences between the Marz Syringe Assist/Accessory System and its predicate device raises no new issues of safety or effectiveness.
5
Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol. The text is in all caps and appears to be in a sans-serif font.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drue Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 10, 2014
Marz Medical Incorporated Ms. Mary Pascual Gallup Vice President of Regulatory Affairs 2500 Hospital Drive, Building 9 Mountain View, California 94040
Re: K131692
Trade/Device Name: Marz Blossom Saline Delivery Assist device Regulation Number: Unclassified Regulation Name: Unclassified Regulatory Class: Unclassified Product Code: LCJ Dated: June 6, 2014 Received: June 9, 2014
Dear Ms. Gallup:
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. Ilisting 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 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); good manufacturing practice requirements as set
6
Page 2 - Ms. Mary Pascual Gallup
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/ResourcesforYou/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K131692
Device Name Blossom Syringe Assist Device
Indications for Use (Describe)
The Marz Blossom Syringe Assist device is intended to be used to assist the clinician in the delivery of sterile saline to fill temporary, removable tissue expanders in accordance with the best judgment of the clinician. Specifically, the Marz Blossom Syringe Assist device is indican in assisting the clinician in delivery of sterile saline into the surgically placed sub-dermal temporary, removable tissue expander.
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)
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
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