(74 days)
Not Found
No
The summary describes a device that uses ECG signal analysis to determine catheter tip location based on P-wave changes. There is no mention of AI, ML, or any related technologies in the device description, intended use, or performance studies. The technology described is based on established physiological signal processing.
No
The Celerity System is intended as a supplemental aid in positioning central venous catheters by providing real-time tip location information and does not directly treat or diagnose a disease or condition.
No
The Celerity System is intended as a "supplemental aid in positioning" and "provides real-time catheter tip location information," rather than diagnosing a disease or condition. It assists in a medical procedure, but does not provide a diagnosis.
No
The device description explicitly lists hardware components such as the Celerity Monitor, ECG Patient Cable, Remote Control Cable, Battery, Power Supply Cord, and ECG Clip Cable.
Based on the provided information, the Celerity System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the system is used to provide real-time tip location information of a central venous catheter by utilizing the patient's cardiac electrical activity (ECG). This involves analyzing physiological signals from the patient's body.
- Device Description: The components listed are related to acquiring and processing electrical signals from the patient (ECG cables, electrodes, monitor).
- Lack of In Vitro Activity: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The Celerity System does not perform any analysis on such specimens.
The Celerity System is a medical device that utilizes physiological signals (ECG) to aid in a medical procedure (PICC placement). It falls under the category of devices used for monitoring or guiding procedures within the body, not for analyzing samples outside the body.
N/A
Intended Use / Indications for Use
The Celerity System 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.
The Celerity System is indicated for use as a supplemental aid in 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. Confirmation of tip placement should be verified according to clinical judgment and established hospital protocol (e.g., chest x-ray, fluoroscopy).
Note: Limiting, but not contraindicated, situations for this technique, are patients where cardiac rhythms may change presentation of the P wave.
- 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 additional confirmation method is necessary to confirm catheter tip location.
Product codes
LJS
Device Description
The Celerity System includes the Celerity Monitor/Software, ECG Patient Cable, Remote Control Cable, Battery, Power Supply Cord and ECG Clip Cable (alligator clip). Procedural accessories including ECG Snap Leads, ECG Electrodes, Cable Cover and Prep Pads are provided as a convenience for the clinician.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
right atrium of the heart via the superior vena cava
Indicated Patient Age Range
adult patients
Intended User / Care Setting
clinician
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)
Design Verification and Validation activities were performed in accordance with Design Control requirements per 21 CFR 820.30 and demonstrate that the subject Celerity System meets predetermined performance specifications.
The performance evaluation plan included testing per the following recognized standards to assess conformance to IEC 60601 (3rd Edition).
| IEC 60601-1 | Medical Electrical Equipment - Part 1: General Requirements
for Safety |
|---------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1-2 | Medical Electrical Equipment - Part 2: General Requirements
for Basic Safety and Essential Performance - Collateral
Standard Electro Magnetic Compatibility - Requirements and
Test |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
0
May 9th, 2014 Medcomp Traditional Premarket Notification Celerity System
510(k) Summary
Date Prepared: May 9th, 2014
JUN 1 3 2014
Submitter Information A.
Submitter: | MEDCOMP® |
---|---|
1499 Delp Drive | |
Harleysville, PA 19438 | |
Tel: | (215) 256-4201, x2271 |
Fax: | (215) 256-9191 |
Contact: | Jessica Leo, Regulatory Associate |
1499 Delp Drive Harleysville, PA 19438 Tel:215-256-4201 Fax:215-256-1787 www.medcompnet.com
B.
C.
Trade Name | Celerity™ System |
---|---|
Common Name: | PICC placement accessory |
Classification Name: | Percutaneous, implanted, long-term intravascular Catheter |
Product Code: | LJS, |
CFR: | 21CFR880.5970 |
Class: | II |
Predicate Devices | K093775; |
Sapiens ™ Tip Location System | |
Romedex International Srl | |
Common Name: | PICC placement accessory |
Classification Name: | Percutaneous, implanted, long- term intravascular Catheter |
Product Code: | LJS, |
CFR: | 21CFR880.5970 |
Class: | II |
D. Device Description
The Celerity System includes the Celerity Monitor/Software, ECG Patient Cable, Remote Control Cable, Battery, Power Supply Cord and ECG Clip Cable (alligator clip). Procedural accessories including ECG Snap Leads, ECG Electrodes, Cable Cover and Prep Pads are provided as a convenience for the clinician.
E. Intended Use
The Celerity System 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.
Image /page/0/Picture/12 description: The image shows the ISO 13485 Certified Quality System logo. The text "ISO 13485" is in large, bold font. Below it, the words "Certified Quality System" are in a smaller font. The logo is black and white.
5-2
1
May 9th, 2014 Medcomp Traditional Premarket Notification Celerity System
F. Indications for Use
The Celerity System is indicated for use as a supplemental aid in 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. Confirmation of tip placement should be verified according to clinical judgment and established hospital protocol (e.g., chest x-ray, fluoroscopy).
Note: Limiting, but not contraindicated, situations for this technique, are patients where cardiac rhythms may change presentation of the P wave.
- 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 additional confirmation method is necessary to confirm catheter tip location.
G. Technological Characteristics
Technological Characteristics of the Celerity System are equivalent with respect to the basic system design and function to that of the predicate device. The differences between the predicate and proposed devices do not raise new questions of safety or effectiveness.
H. Safety and Performance
Design Verification and Validation activities were performed in accordance with Design Control requirements per 21 CFR 820.30 and demonstrate that the subject Celerity System meets predetermined performance specifications.
The performance evaluation plan included testing per the following recognized standards to assess conformance to IEC 60601 (3rd Edition).
| IEC 60601-1 | Medical Electrical Equipment - Part 1: General Requirements
for Safety |
|---------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1-2 | Medical Electrical Equipment - Part 2: General Requirements
for Basic Safety and Essential Performance - Collateral
Standard Electro Magnetic Compatibility - Requirements and
Test |
Substantial Equivalence Conclusion
The proposed device is substantially equivalent to the predicate device based on:
-
The Intended Use .
I. -
Operating principles/technology .
-
. Results of safety and performance testing
-
Responses to questions raised in the FDA 510(k) decision tree .
ર-3
2
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W066-G609 Silver Spring, MD 20993-0002
June 13, 2014
Medcomp® C/O Ms. Lorraine M. Hanley Medical Components, Inc., d.b.a Medcomp 25 Forest Drive Marlborough, MA 01752
Re: K140799
Trade/Device Name: Celerity TM System Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: May 27, 2014 Received: May 27, 2014
Dear Ms. Hanley:
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.
3
Page 2 - Ms. Hanley
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 devicerelated 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/ResourcesforYou/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,
MarySTBper-S
Erin I. Keith. M.S. Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
| | DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use | | Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below. |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | |
| 510(k) Number (if known) | | | |
| Device Name
Celerity PICC Tip Confirmation System | | | |
| | | | |
| Indications for Use (Describe)
activity. Confirmation of tip placement should be verified according to clinical judgement and established hospital
protocol (e.g., chest x-ray, flouroscody). | | | The Celerity System is indicated for use as a supplemental aid in 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 |
| Note: Limiting, but not contraindicated, situations for this technique, are patients where cardiac rhythms may change
presentation of the P wave. | | | |
| -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) |
| | | | PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. |
| | | FOR FOA USE ONLY
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| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | | | |
| | | Digitally signed by
Richard C. Chapman -S | |
| | | Date: 2014.06.13 | |
| | | 14:50:17 -04'00' | |
| | | This section applies only to requirements of the Paperwork Reduction Act of 1995. | |
| | | 'DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW." | |
| | | of this information collection, including suggestions for reducing this burden, to: | The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect |
| | | Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer | |
| | PRAStaff@fda:hhs.gov | Paperwork Reduction Act (PRA) Staff | |
| | | "An agency may not;conduct or sponsor, and;a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number." | |
| FORM FDA 3881 (1/14) | | Page 1 of 1 | |
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