(59 days)
The cable is designed for use only with the Medronic Achieve family of mapping catheters. It is intended to provide the connection of the catheter to a standard ECG interface box.
The Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable is licensed for single use only. It connects the catheter and console to provide a path of electrical transmission from the proximal end of an Achieve mapping catheter to standard shielded ECG pins that connect to standard EP pacing and recording equipment. The cable is designed to only be used with the Medtronic Achieve family of mapping catheters
The provided text describes a 510(k) premarket notification for a reprocessed medical device, the "Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC)". It is fundamentally a comparison to a predicate device, arguing for substantial equivalence through non-clinical testing.
However, the information provided does not contain details about acceptance criteria or a study proving device performance against such criteria in the context of an AI/algorithm-driven medical device.
The document is a regulatory approval letter and a 510(k) summary for a reprocessed physical medical device (a cable), not an AI/software as a medical device (SaMD). Therefore, it does not include:
- Acceptance criteria for an AI/algorithm's performance (e.g., sensitivity, specificity, AUC).
- Details about a test set (sample size, provenance).
- Information on expert ground truth establishment (number of experts, qualifications, adjudication methods).
- Any multi-reader multi-case (MRMC) comparative effectiveness study.
- Stand-alone algorithm performance.
- Ground truth type for AI/algorithm evaluation.
- Training set details for an AI model.
The "Non-clinical Testing Summary" section describes the tests performed for this reprocessed physical device:
- Functional performance: simulated use and artificial soiling; visual inspection; continuity, isolation and resistance device functionality; Electrical Safety current leakage and hipot
- Cleaning Validation
- Sterilization Validation bioburden testing
- Packaging and shelf life validation
- Product stability
These are standard engineering and safety tests for a physical medical device, not performance evaluations for an AI/software.
Therefore, based on the provided text, it is not possible to answer the detailed questions about acceptance criteria and study design for an AI/algorithm-driven medical device. The document simply isn't about that kind of device.
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Image /page/0/Picture/0 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.
June 7, 2024
Surgical Instrument Service and Savings Inc. (dba Medline ReNewal) Stephanie Boyle Mays Senior Regulatory Affairs Specialist, QA/RA 1500 NE Hemlock Ave. Redmond, Oregon 97756
Re: K240972
Trade/Device Name: Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC) Regulation Number: 21 CFR 870.1220 Regulation Name: Catheter, Recording, Electrode, Reprocessed Regulatory Class: Class II Product Code: NLH Dated: April 9, 2024 Received: April 9, 2024
Dear Stephanie Boyle Mays:
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.
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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).
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 QS 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,
Aneesh S. Deoras -S
Aneesh Deoras Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices
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Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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The device(s) included in the scope of the submission are as follows:
- . Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC)
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Indications for Use
510(k) Number (if known) K240972
Device Name
Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC)
Indications for Use (Describe)
The cable is designed for use only with the Medronic Achieve family of mapping catheters. It is intended to provide the connection of the catheter to a standard ECG interface box.
| 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/5/Picture/0 description: The image features the logos of Medline and ReNewal. The Medline logo is on the left and consists of a blue square with a white star-like symbol and the word "MEDLINE" in white letters. To the right of the Medline logo is the ReNewal logo, with "Re" in green and "Newal" in blue. Below "ReNewal" is the text "Full Circle Reprocessing" in a smaller font size.
Traditional 510(k) Notification Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable
K240972 510(k) Summary
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR § 807.92.
| Submitter/Owner | Surgical Instrument Service and Savings (dba Medline ReNewal)1500 NE Hemlock Ave., Redmond, OR 97756 | |
|---|---|---|
| Contact/Prepared by | Stephanie Boyle MaysSenior Regulatory Affairs Specialist, Quality Assurance/Regulatory AffairsP: 541-516-4205 • F: 541-923-3375 • smays@medline.com | |
| Date Prepared | April 9, 2024 | |
| Device Name andClassification | Proprietary/Trade Name: | Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable |
| Common or Usual Name | Catheter, recording, electrode, reprocessed | |
| Regulatory Name/Reference | Electrode recording catheter or electrode recording probe/21 CFR § 870.1220 | |
| Regulatory Class | 2 | |
| Product Code | NLH | |
| Panel | Cardiovascular | |
| Predicate Device | Predicate selection rationale | The predicate models in K153139 include the subject device model of this submission. The predicate catheter connecting cable device and the subject catheter connecting cable device are the same except the subject devices have been reprocessed. |
| 510(k) Number | K153139 | |
| Proprietary or Trade Name | Achieve ST Mapping Catheter, Catheter Connecting Cable | |
| Common or Usual Name | Catheter, recording, or probe electrode recording | |
| Regulatory Name/Reference | Electrode recording catheter/21 CFR § 870.1220 | |
| Regulatory Class | 2 | |
| Product Code | DRF | |
| Panel | Cardiovascular | |
| 510(k) applicant | Medtronic Inc.,710 Medtronic Parkway, Minneapolis, MN 55432 | |
| Device Description | The Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable is licensed for single use only. It connects the catheter and console to provide a path of electrical transmission from the proximal end of an Achieve mapping catheter to standard shielded ECG pins that connect to standard EP pacing and recording equipment. The cable is designed to only be used with the Medtronic Achieve family of mapping catheters | |
| TechnologicalCharacteristics | The technological characteristics, materials, and the fundamental scientifictechnology of the subject device is equivalent to the predicate device. Theproposed device is a reprocessed version of the predicate device. K153139Achieve ST Mapping Catheter, Catheter Connecting Cable was used as theprimary predicate to support intended use, technological characteristics,and functional performance specifications. | |
| Non-clinicalTestingSummary | The functional characteristics of the subject device have been evaluatedand found to be substantially equivalent to the predicate device based onthe following tests:Functional performance: simulated use and artificial soiling; visual inspection; continuity, isolation and resistance device functionality; Electrical Safety current leakage and hipot Cleaning Validation Sterilization Validation bioburden testing; Packaging and shelf life validation; |
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Image /page/6/Picture/0 description: The image contains the Medline Renewal logo. The Medline logo is on the left side of the image and consists of a blue square with a white star and the word "MEDLINE" in white letters. To the right of the Medline logo is the word "Renewal" in large green and blue letters. Below the word "Renewal" is the phrase "Full Circle Reprocessing" in smaller blue letters.
Traditional 510(k) Notification Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable
- Product stability .
Summary Table: Predicate and Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable comparison chart.
| Predicate | Proposed | Comparison | |
|---|---|---|---|
| View | Medtronic Achieve STMapping Catheter, CatheterConnecting Cablea | Medline ReNewalReprocessed MedtronicAchieve CatheterConnecting Cable | As Stated |
| 510(k) | K153139 | K240972s | As stated |
| Model No. | 2ACHC | 2ACHC | Same |
| Common Name | Catheter, recording, or probeelectrode recording | Catheter, recording, or probeelectrode recording,reprocessed | As stated |
| Regulation No. | 21 CFR § 870.1220 | 21 CFR § 870.1220 | Same |
| RegulatoryClass | 2 | 2 | Same |
| Product Code | DRF | NLH | Same |
| Indications forUse | The cable is designed for useonly with the MedtronicAchieve family of mappingcatheters. It is intended toprovide the connection of thecatheter to a standard ECGinterface box. | The cable is designed for useonly with the MedtronicAchieve family of mappingcatheters. It is intended toprovide the connection of thecatheter to a standard ECGinterface box. | Same |
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Image /page/7/Picture/0 description: The image shows the Medline Renewal logo. The Medline logo is on the left, with a blue square containing a white cross and the word "MEDLINE" in white letters. To the right of the Medline logo is the word "Renewal" in large letters, with "Re" in green and "Newal" in blue. Below "Renewal" is the phrase "Full Circle Reprocessing" in smaller, blue letters.
| TechnologicalCharacteristics | The cable provides theconnection between theAchieve catheter and theappropriate console. | The cable provides theconnection between theAchieve catheter and theappropriate console. | Same |
|---|---|---|---|
| Reprocessing | Each cable is reprocessed no more than one time. Medline ReNewal does notreprocess the Achieve Catheter Connecting Cable of other reprocessors. | ||
| Conclusion | The predicate and proposed devices in this application have the sameindications for use and technological characteristics. Based on this and thenon-clinical testing data presented in this 510(k) submission, the MedlineReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable model2ACHC is substantially equivalent to the predicate device. |
§ 870.1220 Electrode recording catheter or electrode recording probe.
(a)
Identification. An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.(b)
Classification. Class II (performance standards).