(442 days)
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.
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 polyurethane-covered wire. The polyurethane-covered wire ends in a two-pin plug connector. 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.
The provided text describes a 510(k) premarket notification for the "Cook-Swartz Doppler Flow Probe." This document is primarily concerned with establishing substantial equivalence to a predicate device and does not contain the information typically found in an AI/ML medical device approval, such as acceptance criteria for algorithm performance, a study design for evaluating AI model accuracy, or details about training and ground truth establishment for an AI model.
The "Cook-Swartz Doppler Flow Probe" is a hardware device (a diagnostic ultrasonic transducer), not an AI/ML algorithm. Therefore, the questions regarding AI/ML specific information (e.g., sample size for test sets, data provenance, number of experts for ground truth, MRMC studies, standalone performance, training set details) are not applicable to the information provided in this document.
The document discusses device performance in terms of mechanical and biocompatibility testing, not AI model performance.
Based on the provided text, here's what can be extracted, acknowledging the limitations for AI/ML-specific questions:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for device performance. Instead, it lists two types of tests conducted and concludes that the device "performs acceptably."
| Test Conducted | Reported Device Performance |
|---|---|
| Cuff detachment force | "Performed acceptably" (implies meeting internal criteria) |
| Suture pad attachment force | "Performed acceptably" (implies meeting internal criteria) |
2. Sample size used for the test set and the data provenance:
N/A for AI/ML performance testing. The document describes physical and biocompatibility testing of a hardware device. No specific sample sizes for these tests are mentioned, nor is data provenance in the context of clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
N/A. This device is a hardware probe, not an AI algorithm requiring expert-established ground truth for image interpretation or diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
N/A. Not relevant for hardware device testing as described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
N/A. This is not an AI-powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
N/A. This is a physical probe, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
N/A. Ground truth in the context of diagnostic performance (as an AI algorithm would have) is not applicable here. The "truth" for this device's performance is determined by its mechanical integrity (detachment/attachment forces) and biocompatibility, likely measured against established engineering or biological safety standards.
8. The sample size for the training set:
N/A. This device does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
N/A. Not applicable as there is no training set for an AI model.
Summary of what the document does provide regarding device evaluation:
- Type of Device: Diagnostic ultrasonic transducer (hardware).
- Purpose of Study: To demonstrate substantial equivalence to a previously cleared predicate device (K022649). This is the primary "study" described, and it's a comparison of specifications and safety documentation.
- "Performance Data": Refers to physical testing (cuff detachment force, suture pad attachment force) and a biocompatibility assessment. 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."
- Biocompatibility Assessment: A comprehensive assessment covering 10 biological effects (Cytotoxicity, Sensitization, Irritation/intracutaneous reactivity, Acute systemic toxicity, Material-mediated pyrogenicity, Subacute/subchronic toxicity, Genotoxicity, Implantation, Chronic toxicity, Carcinogenicity). The conclusion was that materials "provide a reasonable assurance of safety with respect to biocompatibility."
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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.
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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
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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)
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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 | ColorDoppler | Combined(Specify) | Other*(Specify) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| FetalImaging& 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)
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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 Incorporated750 Daniels WayBloomington, 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.
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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 Probeis for monitoring blood flow in vesselsintraoperatively, and followingreconstructive micro-vascularprocedures, 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 |
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| 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 SystemEP42HT epoxy | Master Bond Polymer SystemEP42HT epoxy or Hysol EE0079 &HD0070 two-part epoxy |
| Wire | Neoflon NP-101 FEP-coated wire | Same |
| Suture pads | NuSil MED-4950 or MED-4850silicone | 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:
-
- Cytotoxicity
-
- Sensitization
-
- Irritation or intracutaneous reactivity
-
- Acute systemic toxicity
-
- Material-mediated pyrogenicity
-
- Subacute/subchronic toxicity
-
- Genotoxicity
-
- Implantation
-
- Chronic toxicity
-
- Carcinogenicity
The assessment concluded that the materials of the device provide a reasonable assurance of safety with respect to biocompatibility.
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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.
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
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.(b)
Classification. Class II.