(28 days)
Not Found
No
The summary describes a simple electrical stimulation lead accessory and does not mention any AI or ML capabilities.
No.
The device is used to identify nerves and test nerve and muscle excitability through electrical stimulation. This is a diagnostic function to guide surgical procedures, not a therapeutic one that treats a disease or condition.
Non-Diagnostic Device: Surgical Accessory.
No.
The device's intended use is to provide electrical stimulation for identifying nerves and testing their excitability, and it is an accessory for a stimulator, not a device that independently diagnoses a condition.
No
The device description explicitly states it is a "single-use, sterile medical device accessory" and a "single-patient disposable accessory" with a "lead electrode." This indicates a physical hardware component, not a software-only device. The performance studies also detail testing related to mechanical, electrical, biocompatibility, and packaging aspects, further confirming it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside the body (in vitro).
- Device Function: The Checkpoint Guardian Intraoperative Lead is used to provide electrical stimulation directly to exposed motor nerves or muscle tissue within the body during surgery. This is an in vivo (within the living organism) procedure, not an in vitro test.
- Intended Use: The intended use is to identify nerves and test nerve and muscle excitability through direct electrical stimulation, not to analyze biological samples.
The description clearly indicates the device is used for direct interaction with tissues inside the body during a surgical procedure.
N/A
Intended Use / Indications for Use
The Checkpoint Guardian Intraoperative Lead is a single-use, sterile medical device accessory intended to be used with Checkpoint Stimulators to provide electrical stimulation of exposed motor nerves or muscle tissue to identify nerves and to test nerve and muscle excitability.
Product codes (comma separated list FDA assigned to the subject device)
PDQ, ETN
Device Description
The Checkpoint Guardian Intraoperative Leads are single-patient disposable accessories for providing stimulus to a targeted nerve. The accessories are intended for use with any device from the Checkpoint Stimulator/Locator Family. The lead electrode is intended to wrap around nerves that have been surgically exposed, allowing the surgeons to provide hands free stimulus to a targeted nerve.
Model Numbers include:
- REF 9525 Checkpoint Guardian Intraoperative Lead, Medium (7mm nominal diameter) .
- REF 9526 Checkpoint Guardian Intraoperative Lead, Large (10mm nominal diameter) .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
The Guardian Leads underwent a battery of bench and user tests in accordance with in-house procedures. Design Verification Testing (DVT) conducted on the lead to support this submission demonstrated that all requirements were met including Checkpoint's mechanical and electrical specifications, as well as functionality / performance requirements.
Electrical Safety, general functional testing, and Electromagnetic Immunity / Electromagnetic Compatibility (EMI / EMC) testing for the Checkpoint Stimulator-Locator family was configured and executed in a worst-case configuration to ensure that the stimulation system meets system electrical design specifications and statutory requlations when used in conjunction with associated accessories, including the proposed lead.
Biocompatibility testing was performed on the lead, with all endpoints conforming to limits of BS EN ISO 10993-1:2018 and 2016 FDA guidance titled 'Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" for its intended use as a limited exposure (
§ 874.1820 Surgical nerve stimulator/locator.
(a)
Identification. A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
August 26, 2021
Checkpoint Surgical Ben Cottrill Product Development Manager 6050 Oak Tree Blvd., Suite 360 Independence. Ohio 44131
Re: K212355
Trade/Device Name: Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: Class II Product Code: PDQ, ETN Dated: July 28, 2021 Received: July 29, 2021
Dear Ben Cottrill:
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 (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 located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpm/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.
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 (0S) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 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,
Shu-Chen Peng, Ph.D. Assistant Director DHT1C: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212355
Device Name Checkpoint Guardian Intraoperative Lead
Indications for Use (Describe)
The Checkpoint Guardian Intraoperative Lead is a single-use, sterile medical device accessory intended to be used with Checkpoint Stimulators to provide electrical stimulation of exposed motor nerves or muscle tissue to identify nerves and to test nerve and muscle excitability.
| 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) |
X Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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Special 510(k) Summary
Checkpoint Guardian Intraoperative Lead
In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR §807.92, the following summary of information is provided:
1 Applicant Checkpoint Surgical 6050 Oak Tree Blvd., Suite 360 Independence, OH 44131 Contact Person: Ben Cottrill New Product Development Manager 2 Date Prepared 28/JUL/2021 చి Name of Device
| Device Trade Name: | Checkpoint Guardian Intraoperative Lead |
|---|---|
| Device Common Name: | Intraoperative Lead |
| Class: | |
| Regulation Description: | Class II |
| Surgical nerve stimulator/locator (874.1820) | |
| Classification Name: | Neurosurgical Nerve Locator |
| Stimulator, Nerve | |
| Product Code: | PDQ |
| ETN | |
| Classification Panel: | Neurology |
| Ear Nose & Throat | |
| Predicate Device |
| Manufacturer | Trade Name | Product Code | Submission # |
|---|---|---|---|
| Checkpoint Surgical | Checkpoint | ETN | K092292 |
5 Description of Device
4
The Checkpoint Guardian Intraoperative Leads are single-patient disposable accessories for providing stimulus to a targeted nerve. The accessories are intended for use with any device from the Checkpoint Stimulator/Locator Family. The lead electrode is intended to wrap around nerves that have been surgically exposed, allowing the surgeons to provide hands free stimulus to a targeted nerve.
Model Numbers include:
4
- REF 9525 Checkpoint Guardian Intraoperative Lead, Medium (7mm nominal diameter) .
- REF 9526 Checkpoint Guardian Intraoperative Lead, Large (10mm nominal diameter) .
6 Indications for Use
The Checkpoint Guardian Intraoperative Lead is a single-use, sterile medical device accessory intended for use in conjunction with a Checkpoint Stimulator to provide electrical stimulation of exposed motor nerves or muscle tissue to locate and identify nerves and to test nerve and muscle excitability.
5
| Predicate Devices (K092292) | Guardian Intraoperative Lead | Remark | |
|---|---|---|---|
| Indications | |||
| for Use | The Checkpoint® is a single-use | ||
| device intended to provide electrical | |||
| stimulation of exposed motor nerves | |||
| or muscle tissue to locate and | |||
| identify nerves and to test nerve and | |||
| muscle excitability. | The Checkpoint Guardian | ||
| Intraoperative Lead is a single-use, | |||
| sterile medical device accessory | |||
| intended to be used with | |||
| Checkpoint Stimulators to provide | |||
| electrical stimulation of exposed | |||
| motor nerves or muscle tissue to | |||
| locate and identify nerves and to | |||
| test nerve and muscle excitability. | Same | ||
| Stimulation | |||
| Electrical | |||
| Parameters | |||
| and | |||
| Waveform | Charge balanced cathodic-first | ||
| biphasic current-controlled waveform | |||
| compliant with IEC 60601 2- | |||
| 10:2012+A1:2016. | Charge balanced cathodic-first | ||
| biphasic current-controlled | |||
| waveform compliant with IEC 60601 | |||
| 2-10:2012+A1:2016. | Same | ||
| Stimulation | |||
| Electrode | |||
| Material | 304 Stainless Steel | 304 Stainless Steel | Same |
| Stimulation | |||
| Electrode | Probe | Button contact | SE |
| Charge | |||
| Density | |||
| (µC/cm² ) | Maximum of 12.7 µC/cm² through | ||
| minimum contact surface area. | Maximum of 10.5 µC/cm² through | ||
| minimum contact surface area. | SE | ||
| Insulating | |||
| Material | |||
| at/around | |||
| electrode | |||
| contact | Medical grade polyolefin, MT2000 | Pellethane 2363-80A TPU (a | |
| thermoplastic polyurethane | |||
| elastomer), used extensively for | |||
| both cardiac and deep brain | |||
| stimulation leads. | SE | ||
| Sterilization | Supplied Sterile via validated and | ||
| monitored ETO cycle | Supplied Sterile via SAME validated | ||
| and monitored ETO cycle | Same | ||
| Shelf Life | 2 Years | 2 Years | Same |
| Packaging | |||
| Config. & | |||
| Materials | Stimulator with protective probe | ||
| sleeve in sterile single use Tyvek | |||
| pouch and paperboard shelf carton. | Lead on HDPE backer card, in | ||
| same packaging parts with same | |||
| processes as stimulator. | SE |
Summary Comparison of Technological Characteristics to Predicate 7
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8 Nonclinical Testing
The Guardian Leads underwent a battery of bench and user tests in accordance with in-house procedures. Design Verification Testing (DVT) conducted on the lead to support this submission demonstrated that all requirements were met including Checkpoint's mechanical and electrical specifications, as well as functionality / performance requirements.
Electrical Safety, general functional testing, and Electromagnetic Immunity / Electromagnetic Compatibility (EMI / EMC) testing for the Checkpoint Stimulator-Locator family was configured and executed in a worst-case configuration to ensure that the stimulation system meets system electrical design specifications and statutory requlations when used in conjunction with associated accessories, including the proposed lead.
Biocompatibility testing was performed on the lead, with all endpoints conforming to limits of BS EN ISO 10993-1:2018 and 2016 FDA guidance titled 'Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" for its intended use as a limited exposure (