(167 days)
K 12051
No
The summary describes endoscopic tools and a dilation balloon, with no mention of AI or ML capabilities. The LungPoint Software is mentioned as a guidance system, but its clearance (K12051) would need to be reviewed to determine if it incorporates AI/ML. This summary focuses solely on the physical tools.
Yes
The LungPoint Dilation Balloon is intended to "dilate tissue of the bronchial tree," which is a direct therapeutic action. The LungPoint Sheath also facilitates therapeutic actions by introducing other endoscopic tools.
No
The device description indicates that the LungPoint Tools are endoscopic tools (sheath and dilation balloon) used to assist with procedures inside the bronchial tree, which are therapeutic in nature (providing a working channel, dilating tissue). There is no mention of the device itself being used to identify or analyze a medical condition.
No
The device description explicitly details physical components (LungPoint Sheath, LungPoint Dilation Balloon) made of medical-grade materials, and the performance studies involve testing of these physical components (dimensional testing, joint/tensile test, balloon fatigue/burst pressure, etc.). While it is used in conjunction with LungPoint Software, the device itself is hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The LungPoint Tools are endoscopic tools used within the body during a bronchoscopy procedure. They are used for tasks like providing a working channel, dilating tissue, and introducing other tools.
- Lack of Specimen Analysis: The description does not mention the device being used to analyze any specimens taken from the patient. Its function is entirely procedural and interventional within the respiratory system.
Therefore, the LungPoint Tools fall under the category of medical devices used for surgical or interventional procedures, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The LungPoint Tools are endoscopic tools intended to be used with LungPoint Software guided bronchoscopes. The LungPoint Sheath is intended to be used as a working channel through which endoscopic tools may be introduced to targeted tissue. The LungPoint Dilation Balloon is intended to dilate tissue of the bronchial tree and may be inserted through the LungPoint Sheath or directly through the working channel of the bronchoscope. Not for pediatric use.
Product codes (comma separated list FDA assigned to the subject device)
EOQ
Device Description
The LungPoint Tools are endoscopic tools used during bronchoscopy procedures. The LungPoint Sheath is designed to be used with a bronchoscope to provide a working channel through which endoscopic tools, such as needles, dilation balloons, or other endoscopic devices may be introduced to the targeted lung tissue within the respiratory organs. The LungPoint Dilation Balloon is used to dilate tissue of the bronchial tree and may be inserted through the sheath or directly through the working channel of the bronchoscope. The bronchoscope is advanced to a predefined target following guidance of the LungPoint Software (previously cleared under 510(k) #K 12051 to guide endoscopic tools or catheters in the lungs or to enable marker placement in soft lung tissue).
The materials used in the LungPoint Tools are commonly used medical grade materials and include platinum iridium markers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lung tissue within the respiratory organs, bronchial tree
Indicated Patient Age Range
Not for pediatric use.
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 design and safety of the LungPoint Tools were verified by performing functional and performance testing. All tests were designed to subject the sheath and dilation balloon to stresses that exceed those which would be encountered during clinical use. Testing included the following:
- Dimensional testing -
- Joint/tensile test
- Simulated use -
- Balloon fatigue/burst pressure -
- Balloon deflation time -
- Radiopacity. -
All testing results met the pre-determined acceptance criteria that were established in the test protocols. Based on the testing the LungPoint Tools are as safe, as effective, and perform at least as safely and effectively as the predicate devices.
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.
K 12051
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
§ 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
131234
510(k) Summary
- Date of Summary
October 10, 2013
2. 510(k) Applicant
Broncus Medical, Inc. 1400 N. Shoreline Blvd, Suite A8 Mountain View, California 94043 (650) 428-1600 Phone: FAX: (650) 428-1542
OCT 15 2013
| Contact Person: | Gary Kaplan |
|---|---|
| Phone: | (650) 428-1600 |
| Fax: | (650) 428-1542 |
| e-mail: | gkaplan@broncus.com |
3. Device Overview
| Trade Name: | LungPoint™ Tools (LungPoint Sheath and LungPoint Dilation Balloon) |
|---|---|
| Common Name: | Sheath and Dilation Balloon |
| Classification Name: | Bronchoscope and Accessories |
| 21 CFR 874.4680 | |
| Product Code EOQ |
4. Predicate Device
The predicate devices identified are as follows:
| Trade Name | 510(k) Submitter | 510(k) Number |
|---|---|---|
| CRE Pulmonary Balloon | ||
| Dilatation Catheter | Boston Scientific | |
| Corporation | K023337, cleared to market on | |
| November 18, 2002 | ||
| Olympus Guide Sheath | Olympus Medical | |
| Systems Corporation | K060243, cleared to market on | |
| June 23, 2006 |
5. Device Description
The LungPoint Tools are endoscopic tools used during bronchoscopy procedures. The LungPoint Sheath is designed to be used with a bronchoscope to provide a working
1
channel through which endoscopic tools, such as needles, dilation balloons, or other endoscopic devices may be introduced to the targeted lung tissue within the respiratory organs. The LungPoint Dilation Balloon is used to dilate tissue of the bronchial tree and may be inserted through the sheath or directly through the working channel of the bronchoscope. The bronchoscope is advanced to a predefined target following guidance of the LungPoint Software (previously cleared under 510(k) #K 12051 to guide endoscopic tools or catheters in the lungs or to enable marker placement in soft lung tissue).
The materials used in the LungPoint Tools are commonly used medical grade materials and include platinum iridium markers.
| Catalog
Number | Working Length | Maximum
Catheter Outer
Diameter (OD) | Catheter Internal
Diameter (ID) | Minimum accessory
length for use through
sheath |
|-------------------|----------------|--------------------------------------------|------------------------------------|-------------------------------------------------------|
| 10007-1 | 900mm | 2.65mm | 2.0mm | 965mm |
The LungPoint Sheath has the following specifications:
The LungPoint Dilation Balloon has the following specifications:
| Catalog
Number | Balloon Size
(OD x length) | Rated Balloon
Pressure | Maximum
Catheter Outer
Diameter (OD) | Catheter
Length/working length |
|-------------------|-------------------------------|---------------------------|--------------------------------------------|-----------------------------------|
| 10008-1 | 4mm x 6mm | 20atm | 1mm | 1430mm/975mm |
6. Intended Use
The LungPoint Tools are endoscopic tools intended to be used with LungPoint Software guided bronchoscopes. The LungPoint Sheath is intended to be used as a working channel through which endoscopic tools may be introduced to targeted tissue. The LungPoint Dilation Balloon is intended to dilate tissue of the bronchial tree and may be inserted through the LungPoint Sheath or directly through the working channel of the bronchoscope. Not for pediatric use.
7. Comparison to Predicate Device
The LungPoint Tools are commonly used endoscopic tools with the same technological characteristics as the predicate devices. The indications for use of the LungPoint Tools for use with a bronchoscope guided by the LungPoint Software are all within the intended use of the predicate devices, which is to aid in reaching a target in the respiratory organ
2
either directly as is the case with the sheath or through dilating target tissue with the dilation balloon. The technological characteristics of the subject devices are the same as those of the predicate devices with the following exceptions
- LungPoint Balloon: balloon size and length, balloon burst pressure and balloon . catheter length as outlined.
| | CRE Pulmonary Balloon
Dilatation Catheter
(K023337) | LungPoint Dilation
Balloon |
|--------------------------------------------------|-----------------------------------------------------------|-------------------------------|
| Balloon Size and Inflation
(balloon pressure) | 8mm @ 3 ATM
9mm @ 5.5 ATM
10mm @ 9 ATM | 4mm @ 10 ATM |
| Catheter Length (cm) | 155 | 143 |
| Balloon Length (cm) | 3.0 | 0.6 |
| Rated Burst Pressure (atmospheres) | 9 | 20 |
- LungPoint Sheath: stylet, catheter ID/OD and catheter length as outlined. .
| | Olympus Guide Sheath
(K060243) | LungPoint Sheath |
|-----------------|-----------------------------------|-----------------------------------------------------------------------------------------|
| Stylet Provided | No | Yes - used to enhance
pushability and to prevent
airway mucosa entering
sheath |
| Catheter ID/OD | 2.1/2.7 mm | 2.0/2.6 mm |
| Catheter Length | 900 mm | 975 mm |
None of these differences raise new questions of safety and effectiveness. Performance of the subject devices has been verified by use of accepted methods.
8. Performance Data
The design and safety of the LungPoint Tools were verified by performing functional and performance testing. All tests were designed to subject the sheath and dilation balloon to stresses that exceed those which would be encountered during clinical use. Testing included the following:
- Dimensional testing -
- Joint/tensile test
- Simulated use -
- Balloon fatigue/burst pressure -
- Balloon deflation time -
- Radiopacity. -
All testing results met the pre-determined acceptance criteria that were established in the test protocols. Based on the testing the LungPoint Tools are as safe, as effective, and perform at least as safely and effectively as the predicate devices.
3
9. Safety and Effectiveness
The LungPoint Tools labeling contains instructions for use and any necessary cautions and warnings, to provide for safe and effective use of the devices. The biocompatibility assessment of all patient contacting materials was performed in accordance with ISO 10993. Biological Evaluation of Medical Devices. Specifically, cytotoxicity, sensitization, intracutaneous reactivity and systemic toxicity (acute) were tested. In addition, the devices are sterilized using e-beam sterilization.
10. Conclusion
Based on the testing the LungPoint Tools are as safe, as effective, and perform at least as safely and effectively as the predicate devices.
4
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) in the United States. The logo consists of a stylized graphic element resembling an abstract human form or a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
October 15, 2013
Broncus Medical, Inc. c/o Mr. Mark Job Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, MN 55313
Re: K131234
Trade/Device Name: LungPoint™ Tools (LungPoint Sheath and LungPoint Dilation Balloon) Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible or Rigid) and Accessories Regulatory Class: Class II Product Code: EOQ Dated: August 26, 2013 Received: August 27, 2013
Dear Mr. Job:
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.
5
Page 2 - Mr. Mark Job
""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/CDRH/CDRHOffices/ucm115809.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/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Eric A.Männ -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
6
Indications for Use
510(k) Number (if known): K131234
Device Name:
LungPoint Tools - LungPoint Dilation Balloon and LungPoint Sheath
The LungPoint Tools are endoscopic tools intended to be Indications for Use: used with LungPoint Software guided bronchoscopes. The LungPoint Sheath is intended to be used as a working channel through which endoscopic tools may be introduced to targeted tissue. The LungPoint Dilation Balloon is intended to dilate tissue of the bronchial tree and may be inserted through the LungPoint Sheath or directly through the working channel of the bronchoscope. Not for pediatric use.
× Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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