(117 days)
No
The summary describes a Doppler probe and associated hardware for monitoring blood flow. There is no mention of AI, ML, or any algorithms that would process the Doppler signal using such techniques. The performance studies focus on standard device testing and comparison to a predicate device, not on the performance of any AI/ML model.
No.
The device is intended for monitoring blood flow, not for treating any condition.
Yes
Explanation: The device is intended for "monitoring blood flow in vessels," specifically "peripheral vessels during and following reconstructive microvascular procedures, re-implantation, and free flap transfers." Monitoring blood flow helps assess the health and function of the vessels, which is a diagnostic activity.
No
The device description explicitly lists multiple hardware components including an implantable silicone vessel sleeve, a Doppler transducer (probe), probe wire, suture sleeve, probe connector, and an external lead. It also mentions connecting to a monitor. This is clearly not a software-only device.
Based on the provided information, the FLOW NOW device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the body. IVDs are used to examine specimens such as blood, urine, or tissue to provide information about a person's health.
- FLOW NOW monitors blood flow within the body. The device is implanted to directly monitor blood flow in vessels. It does not analyze samples taken from the patient.
The description clearly states that FLOW NOW is an implantable device that uses ultrasonic Doppler technology to monitor blood flow in vivo. This is a diagnostic tool used within the body, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
FLOW NOW is indicated for monitoring blood flow in peripheral vessels during and following reconstructive microvascular procedures, re-implantation, and free flap transfers. Postoperatively, blood flow can be detected on an as needed basis for up to 7 days. The FLOW NOW Doppler probe is not intended to be a permanent implant and should be removed 3 to 14 days postoperatively.
Product codes (comma separated list FDA assigned to the subject device)
IYN, ITX
Device Description
The GEM FLOW NOW (FLOW NOW) device is comprised of an implantable non-active silicone vessel sleeve (Figure 2), a 20 MHz ultrasonic Doppler transducer (probe) and probe wire, suture sleeve, probe connector, and an external lead that connects to a monitor. FLOW NOW has a soft, pliable silicone "vessel sleeve" that retains the Doppler probe via press-fit into a silicone bore. The device comes with vessel sleeve and probe already assembled.
The FLOW NOW Device is intended for monitoring blood flow in vessels. It is indicated for monitoring blood flow in peripheral vessels intraoperatively, and following reconstructive micro-vascular procedures, re-implantation, and free-flap transfers. Post-operatively, blood flow can be detected on an as needed basis for up to 7 days. The FLOW NOW Doppler probe is not intended to be a permanent implant and should be removed 3 to 14 days post-operatively. The FLOW NOW device is intended for use with both currently cleared FLOW COUPLER Monitors (GEM1020M and GEM1020M-2).
The probe is removed from the patient 3 to 14 days after implantation, once monitoring is complete. The probe is separated from the vessel sleeve and removed from the patient's body. non-invasively, by the surgeon pulling on the probe wire outside the patient's body. The silicone vessel sleeve remains permanently implanted. The FLOW NOW device can be used to monitor blood flow through veins and arteries ranging from 2.0 to 4.0 mm in outside diameter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasonic pulsed doppler
Anatomical Site
Peripheral vessels
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)
Non-Clinical: Bench performance testing was performed after applicable aging, distribution, environmental and/or implantation conditioning to evaluate and compare the technological and performance characteristics. Pre-determined performance specifications were tested, and verification and validation activities were conducted to demonstrate that the GEM FLOW NOW met the defined criteria. Performance evaluation of the GEM FLOW NOW during the design validation and verification was completed by applying methods of internationally recognized standards such as, EN ISO 10993-1:2018 Biological evaluation of medical devices – Part 1: Evaluation and Testing within a risk management process, EN ISO 11737-2:2009, Sterilization of Medical Devices -Microbiological Methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process, EN IEC 62366: 2015, Medical devices – Application of usability engineering to medical device, among others. The GEM FLOW NOW met acceptance criteria and demonstrated comparable performance to the predicate device for the equivalent indications for use.
Clinical: Clinical performance testing was not required for the GEM FLOW NOW device.
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.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
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January 28, 2024
Synovis Micro Companies Alliance Julie Carlston Senior Manager, Regulatory Affairs (A subsidiary of Baxter International Inc.) 439 Industrial Lane Birmingham, Alabama 35211
Re: K233394
Trade/Device Name: GEM FLOW NOW (GEM2770-FN) Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, ITX Dated: October 3, 2023 Received: October 3, 2023
Dear Julie Carlston:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Stephen C. Browning -S
LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K233394
Device Name GEM FLOW NOW (GEM2770-FN)
Indications for Use (Describe)
FLOW NOW is indicated for monitoring blood flow in peripheral vessels during and following reconstructive microvascular procedures, re-implantation, and free flap transfers. Postoperatively, blood flow can be detected on an as needed basis for up to 7 days. The FLOW NOW Doppler probe is not intended to be a permanent implant and should be removed 3 to 14 days postoperatively.
| 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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Image /page/3/Picture/0 description: The image shows the logo for GEM, which stands for Global Excellence in Microsurgery. The logo is in orange and the text "K23339" is above the logo. The logo is a stylized "GEM" with the words "Global Excellence in Microsurgery" below it.
Image /page/3/Picture/1 description: The image contains the word "Baxter" in a stylized, bold, blue font. The font appears to be italicized, with the letters slightly slanted to the right. The word is prominently displayed and takes up a significant portion of the image.
510(k) Summary
I. Submitter's Information
Company Name: Synovis Micro Companies Alliance (A subsidiary of Baxter International Inc.) Address: 439 Industrial Lane, Birmingham Alabama, 35211, USA Establishment Registration Number: 1062741
| Contact Person: | Julie Carlston |
|---|---|
| Phone Number: | +1 (571) 299-9806 |
| Fax Number: | +1 (651) 642-9018 |
| Email Address: | julie_carlston@baxter.com |
Date Prepared: October 3, 2023
II. Device Information
| Trade Name: | GEM FLOW NOW (GEM2770-FN) |
|---|---|
| Common Name: | Ultrasonic pulsed doppler imaging system |
| Classification Name: | System, Imaging, pulsed Doppler, Ultrasonic |
| Regulatory Class: | Class 2 |
| Regulation: | 892.1550 |
| Product Code: | IYN, ITX |
Predicate Device III.
GEM Flow Coupler Device and System K143589 (Reference device: Cook-Swartz Doppler Probe K171272)
Device Description IV.
The GEM FLOW NOW (FLOW NOW) device is comprised of an implantable non-active silicone vessel sleeve (Figure 2), a 20 MHz ultrasonic Doppler transducer (probe) and probe wire, suture sleeve, probe connector, and an external lead that connects to a monitor. FLOW NOW has a soft, pliable silicone "vessel sleeve" that retains the Doppler probe via press-fit into a silicone bore. The device comes with vessel sleeve and probe already assembled.
The FLOW NOW Device is intended for monitoring blood flow in vessels. It is indicated for monitoring blood flow in peripheral vessels intraoperatively, and following reconstructive micro-vascular procedures, re-implantation, and free-flap transfers. Post-operatively, blood flow can be detected on an as needed basis for up to 7 days. The FLOW NOW Doppler probe
4
Image /page/4/Picture/0 description: The image shows the logo for GEM, which stands for Global Excellence in Microsurgery. The logo is in orange and teal colors. The text "K233394" is located at the top left corner of the image.
Image /page/4/Picture/1 description: The image shows the word "Baxter" in a bold, sans-serif font. The word is written in a bright blue color. The letters are slightly slanted to the right, giving the word a dynamic appearance. The background is plain white.
is not intended to be a permanent implant and should be removed 3 to 14 days post-operatively. The FLOW NOW device is intended for use with both currently cleared FLOW COUPLER Monitors (GEM1020M and GEM1020M-2).
The probe is removed from the patient 3 to 14 days after implantation, once monitoring is complete. The probe is separated from the vessel sleeve and removed from the patient's body. non-invasively, by the surgeon pulling on the probe wire outside the patient's body. The silicone vessel sleeve remains permanently implanted. The FLOW NOW device can be used to monitor blood flow through veins and arteries ranging from 2.0 to 4.0 mm in outside diameter.
V. Indications for Use
FLOW NOW is indicated for monitoring blood flow in peripheral vessels during and following reconstructive microvascular procedures, re-implantation, and free flap transfers. Postoperatively, blood flow can be detected on an as needed basis for up to 7 days. The FLOW NOW Doppler probe is not intended to be a permanent implant and should be removed 3 to 14 days postoperatively.
VI. Intended Use
FLOW NOW is intended for monitoring blood flow in vessels.
VII. Technological Characteristics
The technological specification of the GEM FLOW NOW and its predicate device have been evaluated to determine equivalence. As detailed in the Substantial Equivalence section of this 510(k) submission, upon reviewing and comparing intended use, design, principle of operation and overall technology characteristics, GEM FLOW NOW is determined by Synovis Micro Companies Alliance to be substantially equivalent to existing legally marketed devices (Table 1).
| Subject Device | Predicate Device | Determination | |
|---|---|---|---|
| Product Name | GEM FLOW NOW | GEM FLOW COUPLER | |
| System | NA | ||
| 510(k) Holder | Synovis Micro | ||
| Companies Alliance, Inc, | |||
| a subsidiary Of Baxter | |||
| International Inc. | Synovis Micro Companies | ||
| Alliance, Inc, a subsidiary | |||
| Of Baxter International | |||
| Inc. | NA | ||
| 510(k) Number | TBD | K143589 | NA |
| Product Code | IYN, ITX | MVR, DPW | Equivalent |
| Regulation | 892.1550 | 878.4300 | Equivalent |
| Classification | Class II | Class II | Same |
| Subject Device | Predicate Device | Determination | |
| Intended Use | FLOW NOW is intended | ||
| for monitoring blood | |||
| flow in vessels. | The FLOW COUPLER | ||
| Device and System is | |||
| intended to be used in the | |||
| anastomosis of veins and | |||
| arteries normally | |||
| encountered in | |||
| microvascular and vascular | |||
| reconstructive procedures | |||
| and in the detection of | |||
| blood flow and | |||
| confirmation of vessel | |||
| patency following end-to- | |||
| end anastomosis of | |||
| vessels. | Equivalent | ||
| Indications for Use | FLOW NOW is | ||
| indicated for monitoring | |||
| blood flow in peripheral | |||
| vessels during and | |||
| following reconstructive | |||
| microvascular | |||
| procedures, re- | |||
| implantation, and free | |||
| flap transfers. | |||
| Postoperatively, blood | |||
| flow can be detected on | |||
| an as needed basis for up | |||
| to 7 days. The FLOW | |||
| NOW Doppler probe is | |||
| not intended to be a | |||
| permanent implant and | |||
| should be removed 3 to | |||
| 14 days postoperatively. | The FLOW COUPLER | ||
| Device is a single use, | |||
| implantable device that is | |||
| intended to be used in the | |||
| end-to-end anastomosis of | |||
| veins and arteries normally | |||
| encountered in | |||
| microsurgical and vascular | |||
| reconstructive procedures. | |||
| The FLOW COUPLER | |||
| Device includes a pair of | |||
| permanently implanted | |||
| rings which secure the | |||
| anastomosis and a | |||
| removable Doppler probe | |||
| that is press-fit onto one of | |||
| the rings. When the FLOW | |||
| COUPLER Device is used | |||
| in conjunction with the | |||
| FLOW COUPLER | |||
| Monitor, the FLOW | |||
| COUPLER System is | |||
| intended to detect blood | |||
| flow and confirm vessel | |||
| patency intraoperatively | |||
| and post-operatively at the | |||
| anastomotic site. Post- | |||
| operatively, blood flow | |||
| can be detected on an as | |||
| needed basis for up to 7 | |||
| days. The FLOW | |||
| COUPLER Doppler probe | |||
| is not intended to be a | |||
| permanent implant and | |||
| should be removed 3 to 14 | |||
| days post-operatively. | Equivalent. | ||
| How Supplied | Sterile, single use | Sterile, single use | Same |
| Principle of operation | Silicone vessel sleeve is | ||
| secured around the target | |||
| vessel with a vascular | |||
| clip, with the probe in | |||
| liquid contact with the | FLOW COUPLER Device | ||
| implantable rings are used | |||
| to perform end-to-end | |||
| anastomosis of blood | |||
| vessels. The removable | Equivalent | ||
| Subject Device | Predicate Device | Determination | |
| The Doppler probe is | |||
| connected to the FLOW | |||
| COUPLER Monitor via | |||
| the external lead, which | |||
| allows it to transmit a | |||
| Doppler signal caused by | |||
| blood flow. The probe | |||
| wire is secured at the | |||
| skin entry site using the | |||
| suture sleeve. Once | |||
| function is confirmed, | |||
| the surgical site is closed | |||
| using standard | |||
| techniques, with the | |||
| vessel sleeve and | |||
| Doppler probe | |||
| implanted. The Doppler | |||
| probe remains in place | |||
| for 3-14 days, at which | |||
| point it is removed. The | |||
| silicone vessel sleeve is | |||
| permanently implanted. | attached onto one of the | ||
| rings and the probe lead is | |||
| connected to the FLOW | |||
| COUPLER Monitor, | |||
| which detects blood flow. | |||
| Once function is | |||
| confirmed, the surgical site | |||
| is closed using standard | |||
| techniques, while the rings | |||
| and Doppler probe remain | |||
| in place, and the probe | |||
| lead is secured at the skin | |||
| entry site. The doppler | |||
| probe remains in place for | |||
| 3-14 days, at which point it | |||
| is removed. The rings | |||
| permanently implanted. | |||
| Compatible Monitor | GEM FLOW COUPLER | ||
| Monitor | GEM FLOW COUPLER | ||
| Monitor | Same | ||
| Time from | |||
| implantation to probe | |||
| removal | 3-14 days | 3-14 days | Same |
| Monitoring Duration | 7 days | 7 days | Same |
| Vessel size | 2-4mm OD | 2-4 mm OD | Same |
| Biocompatibility | Per ISO 10993 | Per ISO 10993 | Same |
| Sterilization | 10-6 SAL (EtO) | 10-6 SAL (EtO) | Same |
Table 1: Overview of Substantial Equivalence
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Image /page/5/Picture/0 description: The image contains the text "K233394" at the top, followed by the word "GEM" in a large, orange, sans-serif font. Below "GEM" is the text "Global Excellence in Microsurgery" in a smaller, sans-serif font. The word "GEM" is stylized with the letters connected.
Image /page/5/Picture/1 description: The image shows the word "Baxter" in a bold, sans-serif font. The word is written in a bright blue color. The letters are slightly slanted to the right, giving the word a dynamic appearance. The background is plain white, which makes the blue letters stand out.
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Image /page/6/Picture/0 description: The image shows the logo for GEM, which stands for Global Excellence in Microsurgery. The logo is orange and teal. The text "K233394" is located in the upper left corner of the image.
Image /page/6/Picture/1 description: The image shows the word "Baxter" in a bold, blue font. The font is sans-serif and the letters are slightly slanted to the right. The word is centered and takes up most of the image.
VIII. Performance Data
Non-Clinical
Bench performance testing was performed after applicable aging, distribution, environmental and/or implantation conditioning to evaluate and compare the technological and performance characteristics. Pre-determined performance specifications were tested, and verification and validation activities were conducted to demonstrate that the GEM FLOW NOW met the defined criteria.
Performance evaluation of the GEM FLOW NOW during the design validation and verification was completed by applying methods of internationally recognized standards such as, EN ISO 10993-1:2018 Biological evaluation of medical devices – Part 1: Evaluation and Testing within a risk management process, EN ISO 11737-2:2009, Sterilization of Medical Devices -Microbiological Methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process, EN IEC 62366: 2015, Medical devices – Application of usability engineering to medical device, among others.
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Image /page/7/Picture/0 description: The image shows the text "K233394" in the upper left corner. Below the text is the GEM logo in orange. The logo also includes the text "Global Excellence in Microsurgery" in a smaller font.
Image /page/7/Picture/1 description: The image shows the word "Baxter" in a bold, sans-serif font. The word is in blue color. The letters are slightly slanted to the right, giving the word a dynamic appearance. The background is plain white.
The GEM FLOW NOW met acceptance criteria and demonstrated comparable performance to the predicate device for the equivalent indications for use.
Clinical
Clinical performance testing was not required for the GEM FLOW NOW device.
IX. Conclusion
The device is substantially equivalent to the predicate device with respect to indications for use, and technological characteristics and does not raise new questions of safety and effectiveness.