(71 days)
The PICC Tip Positioning Aid is indicated for the positioning of Peripherally Inserted Central Catheters (PICC) in adult patients. It provides real-time catheter tip location by using the patient's cardiac electrical activity. The PICC Tip Positioning Aid is indicated for use as an alternative method to chest x-ray or fluoroscopy confirmation of PICC tip placement in adult patients.
The PICC Tip Positioning Aid includes a standalone Monitor containing software, battery and power cord accompanied by an ECG Patient Cable, a Remote Control Cable, probe cover and ECG Clip Cable.
The provided document does not contain acceptance criteria or a study proving the device meets acceptance criteria. Instead, it is communication from the FDA regarding a 510(k) premarket notification for a device named "PICC Tip Positioning Aid". The document concludes that the device is substantially equivalent to a previously cleared predicate device, the "Celerity System."
The basis for this substantial equivalence is explicitly stated as: "As the only differences between the device and its predicate are names, logos, and addresses in the labeling". Therefore, the "Performance Data" section primarily refers to the existing satisfaction of recognized standards (IEC 60601 series) by the predicate device and a "Simulated Use / Human Factors Testing" that was likely conducted for the predicate device.
To directly address your request, here's what can be extracted and what is missing based on the provided text:
1. Table of acceptance criteria and the reported device performance
No specific quantifiable acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or corresponding reported device performance metrics are provided for the "PICC Tip Positioning Aid" device itself. The document asserts substantial equivalence based on the device being identical to its predicate, except for labeling details.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Simulated Use / Human Factors Testing" but does not provide details on the sample size for this test, its data provenance, or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
A Multi-Reader, Multi-Case (MRMC) comparative effectiveness study for the "PICC Tip Positioning Aid" is not mentioned in the document. The device is described as an "alternative method to chest x-ray or fluoroscopy confirmation" and uses ECG to observe P-wave changes, suggesting it's an automated positioning aid rather than an AI-assisted interpretation tool for human readers in the traditional MRMC sense.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The device is a "PICC Tip Positioning Aid" that "provides real-time catheter tip location by using the patient's cardiac electrical activity." This implies a standalone function of the device to guide placement. However, whether a formal "standalone performance study" was conducted for this specific device (separate from its predicate) is not detailed. The "Simulated Use / Human Factors Testing" mentioned seems to evaluate the application of the entire system as an alternative to X-ray, which would implicitly include the algorithm's performance within the simulated use context. No explicit details of an algorithm-only standalone study are given.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document primarily focuses on the device being "substantially equivalent" to its predicate. For the "Simulated Use / Human Factors Testing" mentioned, the ground truth would likely be established using established methods for confirming PICC tip placement (e.g., actual X-ray or fluoroscopy confirmation as the standard of care it aims to replace), but this is not explicitly stated in the provided text.
8. The sample size for the training set
Since the document indicates the subject device is identical to its predicate in design, production, and technology, there is no mention of a training set for the "PICC Tip Positioning Aid" in this submission. Any training would have occurred for the predicate device, but those details are not included here.
9. How the ground truth for the training set was established
As there's no mention of a training set for this specific device in the submission, this information is not applicable/provided.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 21, 2015
Nostix LLC c/o Mr. Jim Lewis Salus Ventures LLC 5335 Holmes Place Boulder, Colorado, 80303
Re: K152261
Trade/Device Name: PICC Tip Positioning Aid Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, implanted, long-term intravascular catheter Regulatory Class: II Product Code: LJS Dated: August 7, 2015 Received: August 11, 2015
Dear Mr. Lewis:
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. 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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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 (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina
Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
PICC Tip Positioning Aid
Indications for Use (Describe)
The PICC Tip Positioning Aid is indicated for the postioning of Peripherally Inserted Central Catheters (PICC) in adult patients. It provides real-time catheter tip location by using the patient's cardiac electrical activity. The PICC Tip Positioning Aid is indicated for use as an alternative method to chest x-ray or fluoroscopy confirmation of PICC tip placement in adult patients.
Note: In general, devices that utilize ECG technique to observe P-Wave arc limited, but not contraindicated, for patients where cardiac rhythms may change presentation of the P-Wave; including
- Atrial fibrillation
- Atrial flutter
- Severe tachycardia
- Pacemaker-driven rhythm
- Chronic obstructive pulmonary disease (COPD)
Such patients are easily identified prior to PICC insertion. Use of an additional confirmation method is necessary to confirm catheter tip location.
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/3/Picture/0 description: The image shows the word "Nostix" in blue font with a gray shadow. The word is written in a serif font. The shadow is slightly offset from the word, giving it a 3D effect.
510(k) Summary
Prepared: 25 September 2015
Submitter
| Company | Nostix LLC5541 Central Av, Suite 170Boulder, CO 80301 |
|---|---|
| Tel | 303 245 8895 |
| Fax | 303 245 8909 |
| Contact | Pete NelsonDirector of Engineeringpetenelson@nostix.com |
| Device |
| Trade Name | PICC Tip Positioning Aid |
|---|---|
| Common Name | PICC placement accessory |
| Class Name | Percutaneous, implanted, long-term intravascular catheter |
| Product Code | LJS |
| Regulation | 21 CFR 880.5970 |
| Class | 2 |
Predicate
| Trade Name | Celerity System |
|---|---|
| Clearance | K142889, 27 January 2015 |
| Common Name | PICC placement accessory |
| Class Name | Percutaneous, implanted, long-term intravascular catheter |
| Product Code | LJS |
| Regulation | 21 CFR 880.5970 |
| Class | 2 |
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Device Description
The PICC Tip Positioning Aid includes a standalone Monitor containing software, battery and power cord accompanied by an ECG Patient Cable, a Remote Control Cable, probe cover and ECG Clip Cable.
Other procedural accessories; including ECG Snap Leads, ECG Surface Electrodes, Cable Cover, Gloves and Prep Pads; may be provided as a convenience for the clinician but are not in the scope of this submission.
Intended Use
The PICC Tip Positioning Aid is intended to provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via the superior vena cava.
Indications for Use
The PICC Tip Positioning Aid is indicated for the positioning of Peripherally Inserted Central Catheters (PICC) in adult patients. It provides real-time catheter tip location information by using the patient's cardiac electrical activity. The PICC Tip Positioning Aid is indicated for use as an alternative method to chest x-ray or fluoroscopy confirmation of PICC tip placement in adult patients.
Note: In general, devices that utilize ECG technique to observe P-Wave arc limited, but not contraindicated, for patients where cardiac rhythms may change presentation of the P-Wave; including
- Atrial fibrillation 트
- Atrial flutter
- I Severe tachycardia
- Pacemaker-driven rhythm
- I Chronic obstructive pulmonary disease (COPD)
Such patients are easily identified prior to PICC insertion. Use of an additional confirmation method is necessary to confirm catheter tip location.
Technological Characteristics
Technological Characteristics of the subject PICC Tip Positioning Aid are identical to the predicate device. The name and address changes on the labels between the predicate and proposed devices do not raise new technological questions.
Performance Data
As the only differences between the device and its predicate are names, logos, and addresses in the labeling, the following recognized standards from the IEC 60601 (3ra Edition) series continue to be satisfied.
- IEC 60601-1-1 Medical electrical equipment—Part 1-1: General requirements for safety-Collateral standard: Safety requirements for medical electrical systems
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- IEC 60601-1-2 Medical electrical equipment-Part 1-2: General requirements for basic safety and essential performance-Collateral standard: Electromagnetic compatibility - Requirements and tests
Human Factors Evaluation - Simulated Use Testing alternate to chest x-ray and fluoroscopy:
Simulated Use / Human Factors Testing has been conducted to evaluate the application of the PICC Tip Placement Aid as embodied in the predicate Celerity System when used to confirm PICC tip position as an alternative method to chest X-ray or fluoroscopy confirmation. The use related events noted in the studies have been adequately reviewed and addressed in order to ensure the appropriate use of the device as an alternate to x-ray techniques for confirmation of tip location of PICC.
Based on the content of the proposed PICC Tip Positioning Aid's Risk Analysis / Use and Design FMEAs, and the content of the Instructions for Use, the PICC Tip Positioning Aid has demonstrated its suitability for its intended purpose.
Substantial Equivalence Conclusion
As this device design and manufacturing are the same as the predicate except for name changes to the device and the manufacturer, the device is clearly equivalent to its predicate. The proposed device is clearly substantially equivalent to the predicate device based on identical:
- 트 Intended Use
- 트 Indications for Use
- ' Design
- 트 Production
- I Operating principles, characteristics, and user interface
- 트 Technology and specifications
- I Labeling
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”