(46 days)
The Denver Pleurx Catheter Kit and the Denver Pleurx Drainage Kit/Vacuum Bottle are indicated for intermittent long term drainage of symptomatic, recurrent pleural effusion, including malignant pleural effusion and other recurrent effusions that do not respond to medical management of the underlying disease. The devices are indicated for 1) the palliation of dyspnea due to pleural effusion and 2) providing pleurodesis (resolution of the pleural effusion).
The Pleurx Drainage Kit includes a vacuum bottle with drainage line that is connected to the Pleurx catheter for removing fluid that has accumulated in the chest. It also includes a rooedure pack that includes all the supplies needed to perform the drainage procedure and to replace the dressing over the catheter.
The provided text describes a special 510(k) for a modification to the Denver Pleurx Drainage Kit, focusing on changes to the vacuum bottle/drainage line assembly. The acceptance criteria and the study to prove the device meets these criteria are related to demonstrating substantial equivalence to the currently marketed product, specifically regarding flow rate and other design specifications, and applying risk management techniques.
Here's an analysis of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Key safety-critical performance parameter: Flow rate - (Implicit: within the specification for the currently marketed device). | Not explicitly stated what the specific flow rate was, but the sponsor "verified that the key safety-critical performance parameter, flow rate, was within the specification for the currently marketed device." This indicates successful a meeting of the acceptance criteria. |
| Other aspects of the revised bottle design - (Implicit: met the specifications set for them). | Not explicitly stated what these "other aspects" or their specifications were, but the sponsor "verified that other aspects of the revised bottle design met the specifications set for them." This indicates successful a meeting of the acceptance criteria. |
| Risk management techniques applied to changes - (Implicit: potential impact on device safety assessed, appropriate risk control measures adopted). | The sponsor applied "risk management techniques to assess the potential impact of the changes on device safety, and adopting appropriate risk control measures." This indicates successful a meeting of the acceptance criteria. |
2. Sample size used for the test set and the data provenance
The document does not specify a sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). The studies mentioned appear to be internal verification processes rather than clinical trials with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not mention the use of experts to establish ground truth for a test set. The verification process seems to be based on engineering specifications and risk management, not expert consensus on patient outcomes or interpretations.
4. Adjudication method for the test set
The document does not describe any adjudication method, as there's no mention of a test set requiring adjudication by experts.
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
The document does not describe an MRMC comparative effectiveness study. The device is a medical drainage kit, not an AI-assisted diagnostic tool, so such a study would not be applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document does not describe a standalone algorithm performance study. The device is a physical medical device, not an algorithm.
7. The type of ground truth used
The "ground truth" in this context is the engineering specifications and safety parameters of the device and its predicate. This is a technical ground truth related to mechanical performance and safety, rather than clinical ground truth (like pathology or outcomes data).
8. The sample size for the training set
The document does not mention a training set, as the described studies are not for machine learning or AI models.
9. How the ground truth for the training set was established
Not applicable, as there is no training set mentioned.
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KOS1084
JUN 1 3 2005
6. 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 March 17, 2005.
Device Identification
This special 510(k) is for a modification to the Denver Pleurx Drainage Kit.
Intended Use
The Pleurx Drainage Kits are used in conjunction with the Pleural Catheter. The devices are intended for long-term, intermittent drainage of symptomatic, recurrent, please of off usings, including malignant pleural effusions and other pleural effusions that do not respond to treamma of the underlying disease.
Device Description
The Pleurx Drainage Kit includes a vacuum bottle with drainage line that is connected to the Pleurx catheter for removing fluid that has accumulated in the chest. It also includes a rooedure pack that includes all the supplies needed to perform the drainage procedure and to replace the dressing over the catheter.
Summary of the change
The special 510(k) addresses changes in the vacuum bottle/drainage line assembly. These changes include
- A larger bottle size has been introduced .
- A change in material �
- A change in shape .
- A change in the sealing/vacuum access mechanism .
- A change in the length and diameter of the drainage line .
- A change in the sterilization approach, which will maintain sterility of the drainage line � but will not sterilize the interior of the vacuum bottle.
This 510(k) also identified minor changes that had been made previously, including a change in the skin antiseptic from povidone-iodine to 70% alcohol.
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Substantial Equivalence to Currently Marketed Device
The sponsor used the following techniques to determine that the modified design is substantially equivalent to that of the currently marketed product.
- Verifying that the key safety-critical performance parameter, flow rate, was within the . specification for the currently marketed device.
- Verifying that other aspects of the revised bottle design met the specifications set for . them.
- Applying risk management techniques to assess the potential impact of the changes on . device safety, and adopting appropriate risk control measures.
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Image /page/2/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 facing to the right. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
JUN 1 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Denver Biomedical, Incorporated C/O Ms. Nancy Sauer Director, Regulatory Affairs Quality Assurance Evergreen Research, Incorporated 433 Park Point Drive, Suite 140 Golden, Colorado 80401
Re: K051084
Trade/Device Name: Pleurx Catheter and Drainage Kits/Vacuum Bottle Regulation Number: 870.5050 Regulation Name: Patient Care Suction Apparatus Regulatory Class: II Product Code: DWM Dated: May 26, 2005 Received: May 31, 2005
Dear Ms. Sauer:
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.
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Page 2 - Ms. Sauer
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 (240) 276-0115. 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.
Sincerely yours,
Jennie H. Michie Omd.
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 CATHETER AND DRAINAGE KITS/VACUUM BOTTLE
Indications for Use:
The Denver Pleurx Catheter Kit and the Denver Pleurx Drainage Kit/Vacuum Bottle are indicated for intermittent long term drainage of symptomatic, recurrent pleural effusion, including malignant pleural effusion and other recurrent effusions that do not respond to medical management of the underlying disease. The devices are indicated for 1) the palliation of dyspnea due to pleural 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)
Quattie H. Michie Dms.
(Division Sign-Off Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number:_KO51084
Page | of |
(Posted November 13, 2003)
§ 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).