Who is the manufacturer of Cook-Swartz Doppler Flow Probe?

Cook Incorporated filed the 510(k) submission for Cook-Swartz Doppler Flow Probe (K171272).

What is the FDA product code for Cook-Swartz Doppler Flow Probe?

ITX. It is classified under 21 CFR 892.1570 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Cook-Swartz Doppler Flow Probe?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Cook-Swartz Doppler Flow Probe?

Cook-Swartz Doppler Flow Probe (K022649).

Who can help prepare an FDA 510(k) submission like Cook-Swartz Doppler Flow Probe?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Cook-Swartz Doppler Flow Probe

K171272 · Cook Incorporated · ITX · Jul 17, 2018 · Radiology

Device Facts

Record ID	K171272
Device Name	Cook-Swartz Doppler Flow Probe
Applicant	Cook Incorporated
Product Code	ITX · Radiology
Decision Date	Jul 17, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1570
Device Class	Class 2

Intended Use

The Cook-Swartz Doppler Flow Probe is for monitoring blood flow in vessels intraoperatively, and following reconstructive micro-vascular procedures, re-implantation, and free-flap transfers.

Device Story

The Cook-Swartz Doppler Flow Probe is a diagnostic ultrasonic transducer used to monitor blood flow in vessels. It consists of a 1 mm diameter piezoelectric crystal transducer (20 MHz) attached to a silicone cuff, which is secured around a blood vessel. The probe connects via wires to the Swartz Doppler Monitoring System. During intraoperative or post-operative monitoring, the transducer detects blood flow signals, which are processed by the compatible monitor. Healthcare providers use the auditory or visual output from the monitor to assess vessel patency and blood flow status. This real-time monitoring helps clinicians detect vascular compromise early, potentially improving outcomes for reconstructive micro-vascular procedures, re-implantations, and free-flap transfers.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including biocompatibility assessments (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, genotoxicity, implantation, chronic toxicity, carcinogenicity) and mechanical performance testing (cuff and suture pad detachment force).

Technological Characteristics

Piezoelectric crystal transducer (20 MHz); 1 mm diameter disc. Materials: NuSil MED-4750 silicone cuff, NuSil MED-1137 silicone adhesive, Master Bond EP42HT or Hysol EE0079/HD0070 epoxy, Neoflon NP-101 FEP-coated wire, NuSil MED-4050 silicone suture pads. Sterilization: Ethylene oxide. Connectivity: Wired connection to Cook Model DP-M350 monitor.

Indications for Use

Indicated for monitoring blood flow in vessels intraoperatively and post-operatively following reconstructive micro-vascular procedures, re-implantation, and free-flap transfers.

Regulatory Classification

Identification

A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.

Predicate Devices

Cook-Swartz Doppler Flow Probe (K022649)

Related Devices

K964001 — SWARTZ DOPPLER FLOW PROBE AND MONITOR SYSTEM · Med Institute, Inc. · Apr 17, 1998
K022649 — COOK-SWARTZ DOPPLER FLOW PROBE · Cook Vascular, Inc. · Sep 6, 2002
K110347 — DOPPLER MONITOR · Cook Vascular, Inc. · Mar 16, 2011
K233394 — Gem Flow Now (GEM2770-FN) · Synovis Micro Companies Alliance · Jan 28, 2024
K031091 — VTI 20 MHZ GATED DOPPLER · Vascular Technology Incorporated · Apr 23, 2003

Submission Summary (Full Text)

{0}------------------------------------------------ July 17, 2018 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Cook Incorporated % Mr. Thomas Kardos Vice-President, Regulatory Affairs 750 Daniels Way, P.O. Box 489 BLOOMINGTON IN 47402 Re: K171272 Trade/Device Name: Cook-Swartz Doppler Flow Probe Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: ITX Dated: July 12, 2018 Received: July 13, 2018 Dear Mr. Kardos: We have reviewed vour 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. 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 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. {1}------------------------------------------------ Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Michael D'Hara For Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K171272 Device Name Cook-Swartz Doppler Flow Probe Indications for Use (Describe) The Cook-Swartz Doppler Flow Probe is for monitoring blood flow in vessels intraoperatively, and following reconstructive micro-vascular procedures, re-implantation, and free-flap transfers. Type of Use (*Select one or both, as applicable*)X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # Diagnostic Ultrasound Indications for Use Form Device: Cook-Swartz Doppler Flow Probe Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | Clinical Application | | Mode of Operation | | | | | | | |-----------------------------|------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|---------------------| | General (Track 1 Only) | Specific (Tracks 1 & 3) | B | M | PWD | CWD | Color Doppler | Combined (Specify) | Other* (Specify) | | Ophthalmic | Ophthalmic | | | | | | | | | | Fetal | | | | | | | | | Fetal Imaging & Other | Abdominal | | | | | | | | | | Intra-operative (Specify) | | | P | | | | | | | Intra-operative (Neuro) | | | | | | | | | | | Laparoscopic | | | | | | | | | Pediatric | | | | | | | | | | Small Organ (Specify) | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | Adult Cephalic | | | | | | | | | | Trans-rectal | | | | | | | | | | Trans-vaginal | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | Musculo-skeletal (Conventional) | | | | | | | | | | Musculo-skeletal (Superficial) | | | | | | | | | | Intravascular | | | | | | | | | | Other (Specify) | | | | | | | | | | Cardiac Adult | | | | | | | | | Cardiac | Cardiac Pediatric | | | | | | | | | | Intravascular (Cardiac) | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | Intra-cardiac | | | | | | | | | | | Other (Specify) | | | | | | | | | Peripheral | Peripheral vessel | | | | | | | | Vessel | Other (Specify) | | | P | | | | | N = new indication; P = previously cleared by FDA; E = added under this appendix The Cook-Swartz Doppler Flow Probe is intended for use with the Swartz Doppler Monitoring System for monitoring blood flow in vessels intraoperatively, and following reconstructive micro-vascular procedures, re-implantation, and free-flap transfers. Prescription Use Only (Part 21 CFR 801 Subpart D) {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Cook Medical. The word "COOK" is in large, white, sans-serif letters on a gray background. Below the word "COOK" is the word "MEDICAL" in smaller, white, sans-serif letters on a black background. The black background is in the shape of a trapezoid. # 2.0 510(k) SUMMARY ## Cook-Swartz Doppler Flow Probe As required by 21 CFR 807.92 Date Prepared: April 27, 2017 #### Submitted Bv: | Submission: | Traditional 510(k) Premarket Notification | |-----------------------|---------------------------------------------------------------| | Applicant: | Cook Incorporated | | Applicant Address: | Cook Incorporated 750 Daniels Way Bloomington, IN 47404 | | Contact: | Tom Kardos | | Email: | RegSubmissions@CookMedical.com | | Contact Phone Number: | 724-845-8621 | | Contact Fax Number: | 724-845-2848 | | Device Information: | | | Trade Name: | Cook-Swartz Doppler Flow Probe | | Common Name: | Doppler Probe | | Classification Name: | Diagnostic ultrasonic transducer | 21 CFR 892.1570 ITX Radiology II #### Predicate Device: Classification Panel: Regulation: Product Code: Device Class: The Cook-Swartz Doppler Flow Probe, is substantially equivalent to the predicate device, the previously-submitted Cook-Swartz Doppler Flow Probe as described in K022649. #### Device Description The Cook-Swartz Doppler Flow Probe contains a piezoelectric crystal transducer assembly at its distal end. The transducer is a 1 mm diameter disc and operates at 20 MHz. The transducer is attached to a silicone cuff (either 5 mm × 32 mm or 5 mm × 17.4 mm) that is designed to be secured around a blood vessel. Proximal to the cuff, braided wires connect the transducer to suture pads and to a proximal polyurethanecovered wire. The polyurethane-covered wire ends in a two-pin plug connector. {5}------------------------------------------------ Cook Incorporated - Traditional 510(k) Cook-Swartz Doppler Flow Probe April 27, 2017 The cuff is designed to be wrapped around the vessel to be monitored. The length of the cuff represents the circumference of the vessel that can be covered. The cuff is 5 mm wide regardless of length. The width of the cuff represents the length of the vessel that can be covered with the cuff. #### Intended Use The Cook-Swartz Doppler Flow Probe is for monitoring blood flow in vessels intraoperatively, and following reconstructive micro-vascular procedures, reimplantation, and free-flap transfers. #### Comparison to Predicate Device The Cook-Swartz Doppler Flow Probe is substantially equivalent to the predicate device, the previously-submitted Cook-Swartz Doppler Flow Probe as described in K022649. The table below presents the similarities and differences between the two products for substantial equivalence purposes. The differences between the subject device and the predicate device do not raise any new issues of safety and effectiveness. Performance data are available to support substantial equivalence and were developed using acceptable scientific methods for evaluation. | | Cook-Swartz Doppler Flow Probe (K022649) | Cook-Swartz Doppler Flow Probe (Subject of this submission) | |---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------| | Indications for Use | The Cook-Swartz Doppler Flow Probe is for monitoring blood flow in vessels intraoperatively, and following reconstructive micro-vascular procedures, re-implantation, and free- flap transfers. | Same | | Transducer | | | | Type | Piezoelectric crystal | Same | | Signal frequency | 20 MHz | Same | | Signal amplitude | 15 V (peak-to-peak) into 50 Ω | Same | | Transmitter pulse width & repetition frequency | 0.4 μs; 78.1 KHz | Same | | Cuff | | | | Cuff sizes | 27 mm × 25 mm | 37 mm (L) × 5 mm (W) 17.4 mm (L) × 5 mm (W) | | Material | NuSil MED-4850 silicone | NuSil MED-4750 silicone | {6}------------------------------------------------ | | Cook-Swartz Doppler Flow Probe (K022649) | Cook-Swartz Doppler Flow Probe (Subject of this submission) | |---------------------------------|---------------------------------------------|---------------------------------------------------------------------------------------| | Other patient-contact materials | | | | Adhesive | NuSil MED-2000 silicone | NuSil MED-1137 silicone | | Epoxy | Master Bond Polymer System EP42HT epoxy | Master Bond Polymer System EP42HT epoxy or Hysol EE0079 & HD0070 two-part epoxy | | Wire | Neoflon NP-101 FEP-coated wire | Same | | Suture pads | NuSil MED-4950 or MED-4850 silicone | NuSil MED-4050 Silicone | | Other characteristics | | | | Sterilization | Ethylene oxide | Same | | Compatible Monitor | Cook Model DP-M350 | Same | #### Technological Characteristics The transducer, electrical components, and the polyurethane-covered wires and connector of the Cook-Swartz Doppler Flow Probe are unchanged compared to the predicate device; therefore, it was not necessary to retest acoustic and electrical characteristics of the device. A biocompatibility assessment was made, including assessment of the following biological effects: - 1. Cytotoxicity - 2. Sensitization - 3. Irritation or intracutaneous reactivity - 4. Acute systemic toxicity - 5. Material-mediated pyrogenicity - 6. Subacute/subchronic toxicity - 7. Genotoxicity - 8. Implantation - 9. Chronic toxicity - 10. Carcinogenicity The assessment concluded that the materials of the device provide a reasonable assurance of safety with respect to biocompatibility. {7}------------------------------------------------ Cook Incorporated - Traditional 510(k) Cook-Swartz Doppler Flow Probe April 27, 2017 The following tests were conducted and demonstrate the effective performance of the device: - Cuff detachment force ● - Suture pad attachment force ## Conclusion The results of these tests support the conclusion that the Cook-Swartz Doppler Flow Probe performs acceptably and does not raise new questions of safety and effectiveness, thus supporting a determination of substantial equivalence.