(30 days)
The Pleurx Pleural Catheter is intended for long-term, intermittent drainage of symptomatic, recurrent, pleural effusions, including malignant pleural effusions and other pleural effusions that do not respond to treatment of the underlying disease.
The Denver® Pleurx Pleural Catheter Kit (#50-7000) and the Denver® Pleurx Drainage Kit (#50-7500) are indicated for intermittent, long term drainage of symptomatic, recurrent, pleural effusion, including malignant pleural effusion and other recurrent effusions that do not respond entrailing monagement of the underlying disease. The devices are indicated for 1) the palliation to modiour management effusion and 2) providing pleurodesis (resolution of the pleural effusion.
The Pleurx Pleural Catheter is a silicone tube that is partially implanted in the chest cavity. A cuff is included in the tunneled portion of the catheter. The cuff promotes tissue ingrowth, which helps to anchor the catheter and may provide a barrier against infection. The external portion of the catheter includes a valve that remains closed until it is opened with a specific drainage line. When the drainage line is in place, a vacuum source can be used to drain fluid that builds up in the chest cavity.
The provided text describes a 510(k) premarket notification for a medical device, specifically a modification to the Denver Pleural Catheter. It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a formal study with quantitative performance metrics.
Therefore, much of the requested information regarding acceptance criteria, reported performance, sample sizes, expert involvement, and ground truth establishment is not explicitly detailed in the provided document. This type of information is typically found in design verification and validation reports or clinical study summaries, which are often summarized in a 510(k) but not always presented with full detail on performance metrics.
However, based on the provided text, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria (Inferred from text) | Reported Device Performance (Inferred from text) |
|---|---|---|
| Material Equivalence | Biocompatibility | Fabric suitable for use in a long-term tissue implant (as reviewed from existing data). |
| Physical and Chemical Specifications | Fabric with similar physical and chemical specifications as the predicate device's fabric. | |
| Bond Strength | Bond strength between tubing and cuff within specification | Testing ensured bond strength remains within specification. |
| Intended Use | Drainage of symptomatic, recurrent, pleural effusions | Maintains established intended use (long-term, intermittent drainage). |
2. Sample size used for the test set and the data provenance
The document does not explicitly mention a "test set" in the context of performance evaluation for the modified device. The evaluation performed was primarily for substantial equivalence based on material properties.
- No specific sample size for a test set is provided.
- Data provenance is not explicitly stated, but the evaluation involves "reviewing biocompatibility data" and "testing." These likely refer to pre-existing data for the alternate fabric and new testing conducted by the manufacturer, respectively. No country of origin for data is mentioned. The study is retrospective for biocompatibility data review and likely prospective for the physical testing of the new material.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The evaluation focused on material equivalence and bond strength, not on clinical performance requiring expert ground truth establishment for a diagnostic or predictive algorithm.
4. Adjudication method for the test set
Not applicable. The evaluation did not involve a test set requiring adjudication in the context of clinical performance. The review and testing were internal to the manufacturer's quality control/engineering processes.
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
Not applicable. This device is a medical catheter, not an AI-based diagnostic or prognostic tool. Therefore, an MRMC study is not relevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device, not an algorithm.
7. The type of ground truth used
For the material and bond strength evaluation:
- Biocompatibility: Established standards and existing data for the alternate fabric material (e.g., ISO 10993).
- Physical and Chemical Specifications: Manufacturer's internal specifications and comparative analysis with the predicate material specifications.
- Bond Strength: Manufacturer's internal specifications for acceptable bond strength.
8. The sample size for the training set
Not applicable. This is not an AI/algorithm-based device requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/algorithm-based device.
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510(k) Summary
Sponsor Information
Denver Biomedical, Inc. 14998 W. 6th Ave., Bldg. E700 Golden, CO 80401 303-279-7500
Contact Person: Jeff Hill, RA/QA Coordinator
This 510(k) summary was prepared on August 31, 2005.
Device Identification
This special 510(k) is for a modification to the Denver Pleural Catheter. The modification is to add an alternate supplier for the velour fabricate the cuff. The catheter made with the alternate cuff material has been found substantially equivalent to the previously marketed catheter.
Intended Use
The Pleurx Pleural Catheter is intended for long-term, intermittent drainage of symptomatic, recurrent, pleural effusions, including malignant pleural effusions and other pleural effusions that do not respond to treatment of the underlying disease.
Device Description
The Pleurx Pleural Catheter is a silicone tube that is partially implanted in the chest cavity. A cuff is included in the tunneled portion of the catheter. The cuff promotes tissue ingrowth, which helps to anchor the catheter and may provide a barrier against infection. The external portion of the catheter includes a valve that remains closed until it is opened with a specific drainage line. When the drainage line is in place, a vacuum source can be used to drain fluid that builds up in the chest cavity.
Summary of the change
The special 510(k) covers a minor material change: a change in the supplier of the fabric used to make the cuff.
The alternate fabric has been found to be equivalent to the previously used fabric by
- . Reviewing biocompatibility data to ensure that the fabric is suitable for use in a long-term tissue implant.
- Selecting a fabric with similar physical and chemical specifications .
- Testing to ensure that the bond strength between the tubing and the cuff remains within . specification.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA".
OCT 6 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jeff Hill RA/QA Coordinator Denver Biomedical, Incorporated 14998 West 6th Avenue, Building E700 Golden. Colorado 80401
Re: K052436 Trade/Device Name: Pleurx Pleural Catheter Kit Regulation Number: 21 CFR 870.5050 Regulation Name: Patient Care Suction Apparatus Regulatory Class: II Product Code: DWM Dated: September 2, 2005 Received: September 7, 2005
Dear Mr. Hill:
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 cither 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.
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Page 2 - Mr. Hill
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 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 (240) 276-0120. 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/industry/support/index.html.
Sincercly yours,
Chiu Liu, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, 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: Pleurx Pleural Catheter Kit
Indications for Use:
The Denver® Pleurx Pleural Catheter Kit (#50-7000) and the Denver® Pleurx Drainage Kit (#50-7500) are indicated for intermittent, long term drainage of symptomatic, recurrent, pleural effusion, including malignant pleural effusion and other recurrent effusions that do not respond entrailing monagement of the underlying disease. The devices are indicated for 1) the palliation to modiour management effusion and 2) providing pleurodesis (resolution of the pleural effusion.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K052426
16
§ 870.5050 Patient care suction apparatus.
(a)
Identification. A patient care suction apparatus is a device used with an intrathoracic catheter to withdraw fluid from the chest during the recovery period following surgery.(b)
Classification. Class II (performance standards).