(57 days)
The PacePro Wire is intended for use to introduce and position interventional devices within the chambers of the heart, including those used for transcatheter aortic valve procedures.
Additionally, the PacePro Wire can be used for temporary intracardiac pacing by transmitting an electrical signal from an external pulse generator to the heart.
The proposed PacePro Wire is a guidewire that includes functions for a structural wire and a pacing wire (temporary intracardiac pacing by transmitting an electrical signal from an external pulse generator to the heart.). Throughout the submission this will be referred to as either PacePro Wire or Opsens Pacing Wire (OPW). These two names are interchangeable and represent branding name vs. internal descriptive name.
The provided text is a 510(k) summary for the PacePro Wire. It primarily focuses on demonstrating substantial equivalence to a predicate device (SavvyWire) and does not contain information about a study proving the device meets specific acceptance criteria in the context of an AI/human reader performance study. The device is a medical guidewire with temporary pacing capabilities, not an AI-powered diagnostic device.
Therefore, I cannot provide the requested information for acceptance criteria and a study proving device performance in the context of AI/human reader studies, as this information is not present in the provided document.
However, I can extract information related to the device's performance testing as described in the summary, which serves a similar purpose of demonstrating the device meets its design requirements and is safe and effective.
Here's what can be extracted based on the provided text, reinterpreting "acceptance criteria" and "study" in the context of a medical device submission focused on substantial equivalence:
1. Table of Acceptance Criteria (or Performance Tests) and Reported Device Performance
The document details performance tests conducted to show the PacePro Wire's equivalence to its predicate. While not explicitly "acceptance criteria" for an AI algorithm's performance, these are the criteria for the device's physical and functional performance.
| Category | Acceptance Criteria/Test | Reported Device Performance |
|---|---|---|
| Sterilization | Adherence to ISO 11135-1 (Ethylene Oxide sterilization). | "The following standards are utilized to show equivalence of Sterilization...ISO 11135-1 (2014)..." (Implies successful adherence) |
| Packaging | Adherence to ISO 11607-1 (Packaging for terminally sterilized medical devices). | "The following standards are utilized to show equivalence of...Packaging...ISO 11607-1 (2019) – Amendment 1:2023..." (Implies successful adherence) |
| Shelf-life | No specific standard mentioned, but testing was performed. | "The following standards are utilized to show equivalence of...Shelf life:" (Implies successful outcome). |
| Biocompatibility | Adherence to FDA Guidance ISO 10993-1, categorized as "External communicating device – circulating blood," limited exposure up to 24h. | "Biocompatibility evaluation was conducted in accordance with the FDA guidance Use of International Standard ISO 10993-1..." Testing completed: Cytotoxicity, Sensitization, Intracutaneous reactivity, Systemic toxicity (acute), Hemocompatibility, Pyrogenicity, SC5b-9 complement. (Implies successful testing for all listed) |
| Design Verification | Adherence to FDA Guidance "Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling Guidance for Industry and Food and Drug Administration Staff October 2019." | "All Design Requirements were successfully verified for the PacePro Wire device." |
| Mechanical Testing | Included as part of Design Verification. | Part of "All Design Requirements were successfully verified." |
| Particulate Testing | Included as part of Design Verification. | Part of "All Design Requirements were successfully verified." |
| Rapid Pacing Testing | Included as part of Design Verification. | Part of "All Design Requirements were successfully verified." |
| Safety and Effectiveness | No new questions of safety and effectiveness identified after Verification and Validation. | "No new questions of safety and effectiveness were identified during execution of Verification and Validation activities." |
| Pacing Capabilities | Equivalent to predicate device. | "The pacing capabilities of the PacePro Wire is tested to be equivalent to that of the predicate device." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated for each test. For physical device testing, sample sizes typically refer to the number of devices tested for each characteristic (e.g., tensile strength, flexibility, etc.). This detail is not provided in a summary document like a 510(k).
- Data Provenance: The tests are conducted by the manufacturer, Opsens Inc. The data provenance would be internal laboratory testing and third-party lab testing as required for standards like ISO 10993. It's prospective testing conducted specifically for this submission. Country of origin for data is likely Canada (where Opsens Inc. is located) or certified testing labs they utilize elsewhere.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable. The device is a physical guidewire, not a diagnostic AI system requiring expert human interpretation as ground truth. The "ground truth" for this device's performance is established by objective engineering and biological tests against established standards.
4. Adjudication method for the test set
Not applicable, as it's not an AI/human reader study.
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
Not applicable. This is not an AI-powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI-powered device.
7. The type of ground truth used
The "ground truth" for this medical device is based on:
- Compliance with established international and national standards (e.g., ISO 11135-1, ISO 11607-1, ISO 10993-1, FDA Guidance documents for guidewires).
- Engineering specifications and functional requirements of the device.
- Biocompatibility testing results for material safety.
8. The sample size for the training set
Not applicable. This is not an AI-powered device with a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI-powered device with a training set.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
May 24, 2024
Opsens Inc. Marc Chaunet Regulatory Affairs Director 750. Boulevard du Parc Technologique Quebec, QC G1P 4S3 Canada
Re: K240864
Trade/Device Name: PacePro Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX, LDF Dated: March 27, 2024 Received: March 28, 2024
Dear Marc Chaunet:
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"
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(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).
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 mediation-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.
Image /page/1/Picture/8 description: The image shows a digital signature. The signature is for Sara M. Royce. The date of the signature is 2024.05.24, and the time is 12:10:01 -04'00'.
Sara Royce Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics
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and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K240864
Device Name PacePro Wire
Indications for Use (Describe)
The PacePro Wire is intended for use to introduce and position interventional devices within the chambers of the heart, including those used for transcatheter aortic valve procedures.
Additionally, the PacePro Wire can be used for temporary intracardiac pacing by transmitting an electrical signal from an external pulse generator to the heart.
| 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) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ||
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/4/Picture/0 description: The image shows the logo for "opSens". The "op" is in orange, and the "Sens" is in gray. There are three orange dots above the "e" in "Sens".
510(K) Summary for PacePro Wire
SUBMITTER 1.
Address: Opsens Inc.
750, Boulevard du Parc Technologique
Quebec (Quebec) G1P 4S3
Phone: 418.781.0333 ext 3408
Fax Number: 418-781-0024
Contact Person: Marc Chaunet, Regulatory Affairs Director
Email: marc.chaunet@opsens.com
Date Prepared: March 27, 2024
DEVICE 2.
Name of Device: PacePro Wire
Common or Usual Name: Structural guidewire with temporary pacing capabilities
Classification name: Wire, guide, catheter; electrode, pacemaker, temporary
Regulatory Class: II Product
Code: DQX, LDF
PREDICATE DEVICE 3.
The proposed PacePro Wire™ is substantially equivalent to the Opsens existing guidewire, SavyWire™ cleared in K213854 on 09/14/2022.
The subject device is physically the same product as the SavvyWire, without the pressure sensing capabilities. The predicate device has not been subject to a design-related recall.
4. DEVICE DESCRIPTION
The proposed PacePro Wire is a guidewire that includes functions for a structural wire and a pacing wire (temporary intracardiac pacing by transmitting an electrical signal from an external pulse generator to the heart.). Throughout the submission this will be referred to as either PacePro Wire or Opsens Pacing Wire (OPW). These two names are interchangeable and represent branding name vs. internal descriptive name.
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5. INDICATIONS FOR USE
The PacePro Wire is intended for use to introduce and position interventional devices within the chambers of the heart, including those used for transcatheter aortic valve procedures.
Additionally, the PacePro Wire can be used for temporary intracardiac pacing by transmitting an electrical signal from an external pulse generator to the heart.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE 6. DEVICE
The proposed PacePro Wire is substantially equivalent to the SavvyWire™ cleared in K213854 on 09/14/2022.
The proposed PacePro Wire indications for use are essentially the same as for the SawyWire, minus the following portion "while measuring the pressure within the heart allowing calculation of hemodynamic parameters" as the subject device does not feature the pressurement capabilities of the cleared predicate SavvyWire.
The technological characteristics of the proposed PacePro Wire encompass the functionalities of the predicate device including functions for a structural wire, and a pacing wire (temporary intracardiac pacing by transmitting an electrical signal from an external pulse generator to the heart). Each of these functions is fully supported by the relevant predicate device. Identical to the SawyWire, the PacePro Wire is unipolar. This necessitates the use of a separate patient electrode for the positive connection to the external pulse generator. The pacing capabilities of the PacePro Wire is tested to be equivalent to that of the predicate device. No new questions of safety and effectiveness were identified during the execution of Verification and Validation activities.
Therefore, the proposed devices, PacePro Wire meets substantial equivalence requirements with regards to the legally marketed predicate SavvyWire cleared in K213854.
For detailed comparison, refer to the Substantial Equivalence table on the following pages.
| Proposed Device | Predicate Device | Differences | ||
|---|---|---|---|---|
| Regulatory Information | Name | Pace Pro Wire | SavvyWire™ | N/A |
| 510(k)# | Pending | K213854 | N/A | |
| Predicates | K213854 | K151244, K191907 | N/A | |
| Product Code | DQX, LDF | DQX, DXO, LDF | Same except for DXO | |
| Class | 2 | 2 | Same | |
| RegulationNumber | 870.1330, 870.3680 | 870.1330, 870.2870, 870.3680 | Same except for 870.2870 | |
| RegulationGeneric Name | Wire, guide, catheter; electrode, pacemaker, temporary | Wire, guide, catheter; Transducer, pressure, catheter tip, electrode, pacemaker, temporary | Same except for "Transducer, |
T ABLE 1: PACEPRO WIRE COMPARISON TABLE
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Image /page/6/Picture/0 description: The image shows the logo for OpSens. The "op" part of the name is in orange, while the "Sens" part is in gray. There are three orange dots above the "Sens" part of the name. The logo is simple and modern.
| pressure, catheteri tip" | ||
|---|---|---|
| Proposed Device | Predicate Device | Differences | ||
|---|---|---|---|---|
| Intended use | RegulationIntended Use | Coiled wire fits inside apercutaneous catheter for thepurpose of directing thecatheter through a bloodvessel.The device is used to transmita pacing electrical stimulusfrom the pulse generator tothe heart and/or to transmitthe electrical signal of theheart to the pulse generator. | Coiled wire fits inside a percutaneouscatheter for the purpose of directing thecatheter through a blood vessel.Catheter tip transmits mechanical orelectrical property changes in relation tochanges in blood pressure to accessoryequipment for processing.The device is used to transmit a pacingelectrical stimulus from the pulsegenerator to the heart and/or to transmitthe electrical signal of the heart to thepulse generator. | Same except for"Catheter tiptransmitsmechanical orelectrical propertychanges in relationto changes in bloodpressure toaccessoryequipment forprocessing." |
| Indications | The PacePro Wire™ isintended for use to introduceand position interventionaldevices within the chambersof the heart, including thoseused for transcatheter aorticvalve procedures.Additionally, the PaceProWire™ can be used fortemporary intracardiacpacing by transmitting anelectrical signal from anexternal pulse generator tothe heart. | The SavvyWire™ is intended for use tointroduce and position interventionaldevices within the chambers of theheart, including those used fortranscatheter aortic valve procedures,while measuring the pressure within theheart allowing calculation ofhemodynamic parameters.Additionally, the SavvyWire™ can beused for temporary intracardiac pacingby transmitting an electrical signal froman external pulse generator to the heart. | Same except for"while measuringthe pressure withinthe heart allowingcalculation ofhemodynamicparameters" notrelevant for thesubject devicePacePro Wire. | |
| Contraindications | Cerebral vasculature &absence of anti-coagulationtherapy | Cerebral vasculature & absence ofanticoagulation therapy | Same | |
| Prescription Use | Rx Only | Rx Only | Same | |
| SystemComponents | Sterile, disposable guidewire | Sterile, disposable guidewire | Same | |
| Technological Characteristi | Pressure Sensing& SignalTransmissionTechnology | N/A | Fiberoptic sensor & fiber bundleembedded in guidewire. | There are nofiberoptic sensor &fiber bundleembedded in thePacePro Wireguidewire |
| Sterile, SingleUse PatientContactComponent? | Yes | Yes | Same |
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Image /page/7/Picture/0 description: The image shows the logo for "opSens". The "op" is in orange, while the "Sens" is in gray. There are three orange dots above the "ens" in the logo.
| Guidewire OD | 0.035" | 0.035" | Same |
|---|---|---|---|
| GuidewireLength | 280 cm | 280 cm | Same |
| Guidewire ShaftMaterial | Stainless steel | Stainless steel | Same |
| Tip Coating | None (Stainless steel) | None (Stainless steel) | Same |
| Shaft Coating | Teflon (PTFE) | Teflon (PTFE) | Same |
| IntermediateSection Coating | Teflon (PTFE) | Teflon (PTFE) | |
| Tip Configuration | Spiral (XS OD 3.2 cm,S OD 4.2 cm) | Spiral (XS OD 3.2 cm,S OD 4.2 cm) | Same |
| Proposed Device | Predicate Device | Differences | |
|---|---|---|---|
| Guidewire TipDesign | Coiled | Coiled | Same |
| Guidewire TipLength | XS: 2.9 cmS: 3.8 cm | XS: 2.9 cmS: 3.8 cm | Same |
| Radiopaque Tip? | Yes | Yes | Same |
| Pressure SensorLocation | XS: 2.9 cmS: 3.8 cm | XS: 2.9 cmS: 3.8 cm | Same |
| Electrode | Unipolar | Unipolar | Same |
| External PulseGeneratorConnection | Alligator clamp (negativelead) is connected to one ofthe PacePro Wire pacingconnection zones | Alligator clamp (negative lead) isconnected to one of the SavvyWirepacing connection zones | Same |
| Pulse Generatorcompatibility | Compatible with standardexternal pulse generators | Compatible with standard external pulsegenerators | Same |
PERFORMANCE DATA 7.
Sterilization, Packaging, Shelf-life Testing:
The following standards are utilized to show equivalence of Sterilization, Packaging, and Shelf life:
- ISO 11135-1 (2014) Sterilization of health-care products - ethylene oxide - requirements for the development, validation and routine control of a sterilization process for medical devices. (Sterility)
- . ISO 11607-1 (2019) – Amendment 1:2023 Packaging for terminally sterilized medical devices - part 1: requirements for materials, sterile barrier systems and packaging systems
Biocompatibility testing:
The biocompatibility evaluation was conducted in accordance with the FDA guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (Attachment A) published June 16, 2016. This device is categorized in ISO
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10993-1:2018 as "External communicating device – circulating blood" per section 5.2.3 c). The device will have limited exposure, a cumulative sum of single, multiple or repeated duration of contact up to 24 h. Testing completed on this device includes:
- Cytotoxicity
- . Sensitization
- Intracutaneous reactivity
- . Systemic toxicity (acute)
- . Hemocompatibility
- . Pyrogenicity
- SC5b-9 complement
Design Verification:
Testing was conducted based on requirements of the latest FDA guidance document on guidewires: FDA Guidance Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling Guidance for Industry and Food and Drug Administration Staff October 2019. All Design Requirements were successfully verified for the PacePro Wire device.
Design verification testing included:
- Mechanical Testing
- Particulate Testing
- . Rapid Pacing Testing
No new questions of safety and effectiveness were identified during execution of Verification and Validation activities.
Animal studies:
No animal studies were necessary in support of the substantial equivalence of the PacePro Wire as the intended use/indications for use and technological characteristics are equivalent to the predicate device.
Clinical Studies
No clinical studies were necessary in support of the substantial equivalence of the PacePro Wire as the intended use/indications for use and technological characteristics are equivalent to the predicate device.
8. CONCLUSIONS
The results from these tests mentioned above demonstrate that the technological and performance characteristics of the PacePro Wire is comparable to the predicate device, supports the substantial equivalence of the device that is the subject of this 510(k), and ensures the subject device can perform in a manner equivalent to the predicate device for the shared intended use.
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Image /page/9/Picture/0 description: The image shows the logo for "opSens". The "op" is in orange, and the "Sens" is in gray. There are three orange dots above the "s" in "Sens".
The results of the verification/validation tests have demonstrated that the PacePro Wire does not raise any new questions of safety and efficacy and is therefore substantially equivalent to the legally marketed predicate device, the SavvyWire cleared in K213854.
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.