(76 days)
Not Found
No
The device description and intended use focus on a mechanical cutting mechanism and do not mention any computational or learning capabilities.
No
The device is described as an "accessory" that facilitates the removal of a guiding catheter, rather than directly treating a disease or condition. Its function is mechanical (cutting), not therapeutic.
No
Explanation: The device, the RAPIDO™ Cut-Away™ Cutter, is described as an accessory used to facilitate the removal of a guiding catheter after a coronary venous lead is positioned. Its function involves cutting one wall of the guiding catheter to allow its removal from the lead. This is a therapeutic/interventional function, not a diagnostic one (which would involve identifying or characterizing a medical condition).
No
The device description explicitly states it consists of a handle, a stainless steel blade, and a lead management section, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is intended to facilitate the removal of a guiding catheter used in a procedure involving the coronary venous system. This is a surgical/interventional procedure, not a diagnostic test performed on samples outside the body.
- Device Description: The device is a physical tool (a cutter) used to modify a catheter during a medical procedure. It does not involve analyzing biological samples (blood, tissue, etc.) to diagnose a condition.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in samples.
- Providing information for diagnosis, monitoring, or screening.
- Reagents, calibrators, or controls.
The device is a surgical accessory used during a procedure, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The RAPIDO™ Cut-Away™ Cutter is intended to facilitate RAPIDO™ Cut- Away™ Guiding Catheter removal after the Guidant coronary venous lead is positioned.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
The Cutter is an accessory manufactured for use with the RAPIDO Cut-Away Guiding Catheter, for the treatment of Congestive Heart Failure. The Cutter attaches to the lead and cuts one wall of the guiding catheter as it is removed from the patient, allowing the guiding catheter to be removed from the lead. This new removal process is necessitated by the larger IS-1 terminal pin that future leads will incorporate. The Cutter currently has only one manufacturing configuration.
The Cutter consists of three sections; A handle, a stainless steel blade and a lead management section. The lead management section stabilizes the lead, prior to, and during the cutting procedure. After the lead has been fixed in the patient, the cutter is connected to the lead body as close to the catheter hub as possible. Holding the cutter stationary and fixed to a surface, the doctor pulls the catheter against the cutter blade. The hub is cut first and then the catheter section.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary venous system
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)
Testing demonstrated that the RAPIDO Cut-Away Cutters met the acceptance criteria and performed similarly to the predicate device . No new safety or effectiveness issues were raised during the testing program. The RAPIDO Cut-Away Cutter may be considered substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
K 03)459
JUL 2 3 2003
510(K) Summary
1. Device Trade Name RAPIDOTM Cut-Away™ Cutter
2. Device Common Name Cutter
3. Device Description
The Cutter is an accessory manufactured for use with the RAPIDO Cut-Away Guiding Catheter, for the treatment of Congestive Heart Failure. The Cutter attaches to the lead and cuts one wall of the guiding catheter as it is removed from the patient, allowing the guiding catheter to be removed from the lead. This new removal process is necessitated by the larger IS-1 terminal pin that future leads will incorporate. The Cutter currently has only one manufacturing configuration.
The Cutter consists of three sections; A handle, a stainless steel blade and a lead management section. The lead management section stabilizes the lead, prior to, and during the cutting procedure. After the lead has been fixed in the patient, the cutter is connected to the lead body as close to the catheter hub as possible. Holding the cutter stationary and fixed to a surface, the doctor pulls the catheter against the cutter blade. The hub is cut first and then the catheter section.
4. Intended Use
The RAPIDO Cut-Away Cutter is intended to assist with the removal of the RAPIDO Cut-Away Guiding Catheter that is used to access the coronary venous system. The cutter cuts the guiding catheter after lead implantation.
5. Technological Characteristics
Comparisons of the RAPIDO Cut-Away Cutters and predicate devices show that the technological characteristics such as design and intended use are substantially equivalent to the currently marketed predicate device (Medtronic Attain Cutter).
6. Performance Data
Testing demonstrated that the RAPIDO Cut-Away Cutters met the acceptance criteria and performed similarly to the predicate device . No new safety or effectiveness issues were raised during the testing program. The RAPIDO Cut-Away Cutter may be considered substantially equivalent to the predicate device.
7. Conclusion
The Guidant RAPIDO Cut-Away Cutters are substantially equivalent to the currently marketed Medtronic Attain Cutters (K024035, cleared 12/30/02) with regards to intended use and design.
1
Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three wavy lines or ribbons, which are arranged in a way that suggests movement or flow. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 3 2003
Guidant Corporation Cardiac Rhythm Management c/o Mr. Shah Hilali Senior Regulatory Affairs Associate 4100 Hamline Avenue North St. Paul, MN 55112-5798
Re: K031459
Trade Name: RAPIDOTM Cut-Away™ Cutter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (two) Product Code: DQY Dated: May 7, 2003 Received: May 8, 2003
Dear Mr. Hilali:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
2
Page 2 - Shah M. Hilali
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
N. Quattlebaum, MD
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE STATEMENT
Applicant: Guidant Corporation 4100 Hamline Avenue North St. Paul, MN 55112
510(k) Number (if known): To be assigned by FDA (そのるハイラリ
Device Names: RAPIDO™ Cut-Away™ Cutter
Intended Use/Indications for Use:
The RAPIDO™ Cut-Away™ Cutter is intended to facilitate RAPIDO™ Cut- Away™ Guiding Catheter removal after the Guidant coronary venous lead is positioned.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter __
(Optional Format 1-1-96)
DeaTTM
510(k) Number K031459