(266 days)
No
The device description focuses on the mechanical aspects of a cytology brush and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML. The performance studies described are standard mechanical and biological tests for a medical device.
No
The device is designed for retrieving specimens for biopsy and tissue analysis, which is a diagnostic purpose, not a therapeutic one.
No
The device is designed to obtain tissue samples for biopsy, which are then used for "standard tissue analysis." While the tissue analysis might be diagnostic, the device itself is a collection tool, not one that performs a diagnostic function.
No
The device description clearly details a physical medical device with hardware components (catheter, sheathing, brushes, thumb ring, wire shaft) designed for tissue sample retrieval. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro) to analyze these samples.
- Device Function: The superDimension® Triple Needle Cytology Brush is a tool used inside the body (in vivo) during an endoscopic procedure to collect tissue samples. It is a biopsy device, not a device that performs analysis on a sample.
- Intended Use: The intended use is to "retriev[e] specimens from patients." This describes the act of obtaining the sample, not analyzing it.
- Device Description: The description focuses on the physical design and mechanism for collecting tissue samples. There is no mention of reagents, analytical processes, or anything related to testing the collected sample.
- Performance Studies: The performance studies described focus on the device's ability to collect tissue safely and effectively (e.g., tissue collection, safety testing in a porcine model), not on the accuracy or performance of any diagnostic test.
The collected tissue samples would likely be sent to a laboratory for in vitro diagnostic testing (e.g., cytology, histology), but the device itself is the instrument used for the in vivo collection of the sample.
N/A
Intended Use / Indications for Use
To be utilized through a flexible endoscope or the superDimension system by physicians who are trained in endoscopic techniques for retrieving specimens from patients with endobronchial lesions, peripheral lung nodules, or lung masses.
Product codes
BTG
Device Description
The superDimension® Triple Needle Cytology Brush is designed to obtain tissue samples for biopsy from endobronchial lesions, peripheral lung nodules, or lung masses. The superDimension® Triple Needle Cytology Brush is an endoscopic catheter comprised of an outer Ethylene Tetrafluoroethylene (ETFE) sheathing and an inner catheter assembly. The inner catheter assembly consists of a thumb ring at the proximal end and a twisted wire shaft to connect to the distal end. The distal end terminates in three connected brushes available in two lengths: 10 mm and 15mm. The brushes have sharpened ends, referred to as needle-tipped, that can be used to rough up tissue to obtain a sample of tissue or cells. When the catheter is inserted into a channel such as a bronchoscope or superDimension Extended Working Channel (EWC) with the distal brush in a retracted position inside the outer sheath. When the catheter is in position, the brushes can be extended into the tissue to obtain tissue samples by advancing the proximal thumb ring. When the physician believes that an adequate sample has been taken, the brushes are retracted back into the sheath and then the entire catheter is withdrawn from the channel The superDimension® Triple Needle Cytology Brush is for standard tissue analysis. similar to currently marketed cytology brushes except that it has three smaller brushes in place of one larger brush.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
endobronchial lesions, peripheral lung nodules, or lung masses
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians who are trained in endoscopic techniques
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)
In-vitro and in-vivo testing has been performed on all components, subassemblies, and /or full devices. The results showed that the device met the required specifications for the completed tests and performed similarly to the predicate devices. Testing included the following:
- In Vitro Testing .
- Radiographic Testing o
- Catheter Tensile Testing o
- Dimensional Testing o
- 0 Simulated Use Testing
- Trackability Testing O
- Shelf Life Testing per ASTM F1980-07, ASTM F2096-11, and ASTM F88-09 0
- Distribution Testing per ASTM D4169-09 o
- Sterilization Testing per ISO 11135-1 o
- 0 Biocompatibility Testing (cytotoxicity, irritation, sensitization) per ISO 10993-1. ISO 10993-5, ISO 10993-7, ISO 10993-10
- In Vivo Testing in a porcine model
- o Tissue Collection
- o Safety Testing
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
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the word "COVIDIEN" in bold, sans-serif font. To the left of the word is a black square with a white cross in the center. The cross is formed by two perpendicular white rectangles, creating a medical symbol.
510(k) Summary K130357 Covidien IIc, dba superDimension Inc. SuperDimension® Triple Needle Cytology Brush
| Date Prepared: | 11/4/2013 | |
|---|---|---|
| 510(k) Applicant: | Covidien llc, formerly registered as superDimension Inc. | |
| 161 Cheshire Lane Suite 100 | ||
| Plymouth, MN 55441 U.S.A. | ||
| Contract Person: | Deborah Fleetham , Manager Regulatory Affairs | |
| Phone: 763-210-4091 | ||
| Fax: 763-210-4098 | ||
| Email : deborah.fleetham@covidien.com | NOV 0 6 2013 | |
| Name of Device : | ||
| Trade Name : | superDimension® Triple Needle Cytology Brush | |
| Common Name: | Bronchial Biopsy Brush | |
| Classification Name: | Bronchoscope (flexible or rigid) and accessories | |
| 21 CFR Part 874.4680 | ||
| Product code: | BTG |
Equivalent Legally-Marketed Devices:
K834402 Gastrointestinal Sheath Brush (KOG) by Hobbs Medical, Inc. K944650 Wang Bronchial Needle Brush (EOQ) by ConMed
Description:
The superDimension® Triple Needle Cytology Brush is designed to obtain tissue samples for biopsy from endobronchial lesions, peripheral lung nodules, or lung masses. The superDimension® Triple Needle Cytology Brush is an endoscopic catheter comprised of an outer Ethylene Tetrafluoroethylene (ETFE) sheathing and an inner catheter assembly. The inner catheter assembly consists of a thumb ring at the proximal end and a twisted wire shaft to connect to the distal end. The distal end terminates in three connected brushes available in two lengths: 10 mm and 15mm. The brushes have sharpened ends, referred to as needle-tipped, that can be used to rough up tissue to obtain a sample of tissue or cells. When the catheter is inserted into a channel such as a bronchoscope or superDimension Extended Working Channel (EWC) with the distal brush in a retracted position inside the outer sheath. When the catheter is in position, the brushes can be extended into the tissue to obtain tissue samples by advancing the proximal thumb ring. When the physician believes that an adequate sample has been taken, the brushes are retracted back into the sheath and then the entire catheter is withdrawn from the channel The superDimension® Triple Needle Cytology Brush is for standard tissue analysis. similar to currently marketed cytology brushes except that it has three smaller brushes in place of one larger brush.
1
Intended Use:
To be utilized through a flexible endoscope or the superDimension system by physicians who are trained in endoscopic techniques for retrieving specimens from patients with endobronchial lesions, peripheral lung nodules, or lung masses.
Summary of Substantial Equivalence:
The superTrax Triple Needle-Tipped Cytology brush is substantially equivalent to the ConMed Needle-Tipped Cytology Brush and the Hobbs Cytology Brush predicate devices in the following attributes:
- Indications for Use .
- Mechanism of action .
- Length .
- . Sterilization technique
- Design .
- Size .
- Materials .
- Packaging
- Performance Characteristics 0
The difference between the predicate devices and the superDimension Triple Needle Cytology Brush is that the predicate devices have one, larger brush on the distal end compared to three smaller, flexible brushes on the distal end of the superDimension Triple Needle Cytology Brush.
Performance Data:
In-vitro and in-vivo testing has been performed on all components, subassemblies, and /or full devices. The results showed that the device met the required specifications for the completed tests and performed similarly to the predicate devices. Testing included the following:
- In Vitro Testing .
- Radiographic Testing o
- Catheter Tensile Testing o
- Dimensional Testing o
- 0 Simulated Use Testing
- Trackability Testing O
- Shelf Life Testing per ASTM F1980-07, ASTM F2096-11, and ASTM F88-09 0
- Distribution Testing per ASTM D4169-09 o
- Sterilization Testing per ISO 11135-1 o
- 0 Biocompatibility Testing (cytotoxicity, irritation, sensitization) per ISO 10993-1. ISO 10993-5, ISO 10993-7, ISO 10993-10
- In Vivo Testing in a porcine model
- o Tissue Collection
- o Safety Testing
Clinical Data:
.
Clinical tests were not required to validate the design of the SuperDimension® Triple Needle Cytology Brush due to the extensive history of similar devices.
2
Conclusion :
Based on the intended use, technological characteristics, and results from safety and performance testing, the superDimension Triple Needle Cytology Brush is substantially. equivalent to the legally marketed predicate devices, Gastrointestinal Sheath Brush (KOG) by Hobbs Medical, Inc. K834402, and the Wang Bronchial Needle Brush (EOQ) by ConMed K944650.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
November 6, 2013
Covidien Llc c/o Ms. Deborah Fleetham Manager, Regulatory Affairs 161 Cheshire Lane, Suite 100 Minneapolis, MN 55441
Re: K130357
Trade/Device Name: Superdimension Triple-Needle Cytology Brush Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible or Rigid) and Accessories Regulatory Class: Class II Product Code: BTG Dated: September 27, 2013 Received: September 30, 2013
Dear Ms. Fleetham:
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 11 (Special Controls) or class 111 (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.
4
Page 2 - Ms. Deborah Fleetham
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm 115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/Medica|Devices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Eric A. Mann -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K130357
Device Name: superDimension® Triple Needle Cytology Brush
Indications For Use:
To be utilized through a flexible endoscope or the superDimension system by physicians who are trained in endoscopic techniques for retrieving specimens from patients with endobronchial lesions, peripheral lung nodules, or lung masses.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Sunny Park
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