(84 days)
The Aspira® Peritoneal Drainage System is indicated for intermittent drainage of recurrent and symonomalic malignant asciles. The catheter is intended for long-term access of the perionely in order is intended is intended for long-term access of the peritoneal cavity in order to relieve symptoms such as dyspnea or other symptoms associated with malignant ascites.
The Aspira® Drainage Bag is indicated for use only with the Aspira® Drainage Catheter for intermittent drainage for intermittent drainage.
The Aspira® Dressing Kit is indicated for dressing of a catheter and exit site.
The Aspira® Luer/Universal Adapter is intended to provide access to the Aspira® Drainage Catheter. It is used to drain fluid using standard wall suction, water seal drainage system, glass vacum bottle, syringe or other suction, water drainage system, glass vacuum bottle, syringe or other appropriate method.
The Aspira® Valve Assembly altaches to the Aspira® Drainage Catheter. The Aspira® Repair of the Aspira" Aspira" Drainage Catheter. The Aspira Repair Kit is for the repair of the Aspira" Drainage Catheter and replacement of the Aspira® Valve Assembly.
The Aspira* Peritoneal Drainage System provides patients with a convenient method to relieve malignant ascites symptoms at home. The primary components of the Aspira* Peritoneal Drainage System are the Aspira* Peritoneal Drainage Catheter and the Aspira* Drainage Bag. The Aspira* Peritoneal Drainage System.
This document, outlining a Special 510(k) Premarket Notification for the Aspira® Peritoneal Drainage System, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove performance against specific acceptance criteria for a new device. Therefore, a direct response to all parts of your request for "acceptance criteria and the study that proves the device meets the acceptance criteria" cannot be fully provided in the context of this regulatory document.
However, based on the information provided, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document does not present specific quantitative "acceptance criteria" for clinical performance. Instead, it states that "Verification and validation activities were designed and performed to demonstrate that the subject Aspira® Peritoneal Drainage System met predetermined performance specifications." The general "reported device performance" is that "The subject device met all pre-determined acceptance criteria and demonstrated substantial equivalence as compared to the predicate device."
The document lists several standards and guidance documents that were used to determine appropriate methods for evaluating the performance of the device. These indirectly form the basis of the "acceptance criteria" in a regulatory submission context, as compliance with these standards demonstrates safety and effectiveness.
| Acceptance Criteria (based on standards/guidance) | Reported Device Performance |
|---|---|
| Biological Evaluation (ISO 10993-1:2009, ISO 10993-7:2008, AAMI TIR 19:1998) | Met requirements (verified through testing per standards) |
| Conical Fittings (Luer) Requirements (ISO 594-1:1986, ISO-594-2:1998) | Met requirements (verified through testing per standards) |
| Sterile Drainage Catheters and Accessory Devices (EN 1617:1997, EN 1618:1997) | Met requirements (verified through testing per standards) |
| Packaging for Terminally Sterilized Medical Devices (ISO 11607-1,2:2006, ISTA -1G:2005) | Met requirements (verified through testing per standards) |
| Sterilization (Ethylene Oxide) Validation and Routine Control (BS EN 550:1994, ISO 11135-1:2007) | Met requirements (verified through testing per standards) |
| Overall safety and effectiveness (based on technological characteristics compared to predicate, and compliance with 21 CFR 820.30) | Demonstrated substantial equivalence to predicate device |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a sample size for a clinical test set for the device performance. The listed "Safety & Performance Tests" are primarily related to bench testing and material evaluations (e.g., biocompatibility, sterility, packaging, Luer fittings), not clinical trials with human subjects. There is no mention of data provenance (country of origin, retrospective/prospective clinical data).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable to this document. The listed "tests" are primarily engineering, chemical, and biological evaluations against harmonized standards, which do not typically involve experts establishing clinical ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as there is no mention of a clinical test set requiring adjudication. The document reports on in-house engineering and laboratory testing.
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
This is not applicable. The device is a physical medical device (peritoneal drainage system), not an AI-powered diagnostic tool, and therefore MRMC studies or AI assistance metrics are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The device is not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the "tests" listed (biocompatibility, fittings, sterilization, etc.), the "ground truth" would be compliance with the specific parameters and thresholds defined within the referenced international standards (e.g., biological response within acceptable limits, fitting dimensions meeting specified tolerances, sterility assurance level achieved). These are objective measurements rather than an expert consensus on clinical findings or pathological diagnoses.
8. The sample size for the training set
This is not applicable. There is no mention of a training set as the device is not an AI/machine learning system.
9. How the ground truth for the training set was established
This is not applicable. There is no training set for this type of device.
In summary: This document is a regulatory submission demonstrating substantial equivalence for a physical medical device, not a research paper detailing a study of a novel device against clinical acceptance criteria. The "proof" of meeting acceptance criteria comes from successful completion of various bench and lab tests according to recognized international standards and guidance documents, which are used to show that the device is as safe and effective as its predicate.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 18, 2017
C.R. Bard, Inc. Henry Boland Regulatory Affairs Specialist 605 North 5600 West Salt Lake City, UT 84116
Re: K110396
Trade/Device Name: Aspira® Peritoneal Drainage System Regulation Number: 21 CFR §876.5630 Regulation Name: Peritoneal dialysis system and accessories Regulatory Class: II Product Code: PNG Dated: April 6, 2011 Received: April 8, 2011
Dear Henry Boland:
This letter corrects our substantially equivalent letter of May 6, 2011.
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.
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.
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Page 2 - Henry Boland
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR 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 contact the Division of Industry and Consumer Education 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. 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/ReportalProblem/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 Industry and Consumer Education 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,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Bard Access Systems, Inc. Aspira* Peritoneal Drainage Syslem Special 510(k) Premarket Notification
Indications for Use Statement
510(k) Number (if known): K10396
Device Name: Aspira® Peritoneal Drainage System
Indications for Use:
The Aspira® Peritoneal Drainage System is indicated for intermittent drainage of recurrent and symonomalic malignant asciles. The catheter is intended for long-term access of the perionely in order is intended is intended for long-term
access of the peritoneal cavity in order to relieve symptoms such as dyspnea or other symptoms associated with malignant ascites.
The Aspira® Drainage Bag is indicated for use only with the Aspira® Drainage Catheter
for intermittent drainage for intermittent drainage.
The Aspira® Dressing Kit is indicated for dressing of a catheter and exit site.
The Aspira® Luer/Universal Adapter is intended to provide access to the Aspira® Drainage Catheter. It is used to drain fluid using standard wall suction, water seal drainage system, glass vacum bottle, syringe or other suction, water
drainage system, glass vacuum bottle, syringe or other appropriate method.
The Aspira® Valve Assembly altaches to the Aspira® Drainage Catheter. The Aspira® Repair of the Aspira" Aspira" Drainage Catheter. The Aspira
Repair Kit is for the repair of the Aspira" Drainage Catheter and replacement of the Aspira® Valve Assembly.
Prescription Use X Over-The-Counter Use (Part 21 CFR 801 Subpart D) AND/OR (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)
Helena Sauer
of Reproductiv
· 14 ·
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Bard Access Systems, Inc. Aspira® Peritoneal Drainage System Special 510(k) Premarket Notification -Page 16-01-02-PAGE I OF 3
510(k) Summary 21 CFR 807.92
MAY
Aspira* Peritoneal Drainage System
| GeneralProvisions | Submitter Name:Submitter Address: | Bard Access Systems, Inc.605 North 5600 WestSalt Lake City, UT 84116 |
|---|---|---|
| Contact Person: | Henry BolandRegulatory Affairs Specialisthenry.boland@crbard.com801.522.5000 ext. 5428801.522.5425 fax | |
| Date of Preparation: | 9 February 2011 | |
| Subject Device | Trade Name: | Aspira* Peritoneal Drainage System |
| Classification Name: | Peritoneal Dialysis System and Accessories21 CFR 876.5630 - Class IIFJS - Peritoneal dialysis system and accessories | |
| PredicateDevice | Trade Name: | Aspira* Peritoneal Drainage System |
| Classification Name: | Peritoneal Dialysis System and Accessories21 CFR 876.5630 - Class IIFJS - Peritoneal dialysis system and accessories | |
| Premarket Notification: | K081288, concurrence date 18 July 2008 | |
| Manufacturer. | Bard Access Systems, Inc. | |
| DeviceDescription | The Aspira* Peritoneal Drainage System provides patients with a convenientmethod to relieve malignant ascites symptoms at home. The primarycomponents of the Aspira* Peritoneal Drainage System are the Aspira*Peritoneal Drainage Catheter and the Aspira* Drainage Bag. The Aspira*Peritoneal Drainage System. | |
| Intended Use | The Aspira* Peritoneal Drainage System is intended for long-term access of theperitoneal cavity in order to relieve symptoms such as dyspnea or other symptomsassociated with malignant ascites. | |
| Indications forUse | The Aspira* Peritoneal Drainage System is indicated for intermittent drainage ofrecurrent and symptomatic malignant ascites. The catheter is intended for long-term access of the peritoneal cavity in order to relieve symptoms such as dyspneaor other symptoms associated with malignant ascites. | |
| TechnologicalCharacteristics | Technological characteristics of the subject Aspira* Peritoneal Drainage Systemare equivalent with respect to the basic catheter design and function to those ofthe predicate devices. Differences do not raise any new questions regardingsafety and effectiveness. | |
| Safety &PerformanceTests | Verification and validation activities were designed and performed todemonstrate that the subject Aspira* Peritoneal Drainage System metpredetermined performance specifications. The following guidancedocuments and standards in conjunction with in-house protocols were used todetermine appropriate methods for evaluating the performance of the device: | |
| ISO 10993-1:2009 | Biological Evaluation of Medical Devices Part 1:Evaluation and Testing | |
| ISO 10993-7:2008 | Biological Evaluation of Medical Devices Part 7:Ethylene Oxide Sterilization Residuals | |
| ISO 594-1:1986 | Conical Fittings with 6% (Luer) Taper for Syringes,Needles and Certain Other Medical Equipment -Part 1: General Requirements | |
| ISO-594-2:1998 | Conical Fittings with 6% (Luer) Taper for Syringes,Needles and Certain Other Medical Equipment -Part 2: Lock Fittings | |
| EN 1617:1997 | Sterile Drainage Catheters and Accessory Devicesfor Single Use | |
| EN 1618:1997 | Catheters Other Than Intravascular Catheters -Test Methods for Common Properties | |
| ISO 11607-1,2:2006 | Packaging for Terminally Sterilized Medical Devices | |
| ISTA -1G:2005BS EN 550:1994 | International Safe Transit Authority Procedure 1GSterilization of Medical Devices - Validation andRoutine Control of Ethylene Oxide Sterilization | |
| ISO 11135-1:2007 | Sterilization of health care products- EthyleneOxide - Validation and Routine Control ofSterilization Processes for Medical Devices | |
| AAMI TIR 19:1998 | Guidance for ANSI/AAMI/ISO 10993-7:1995,Biological Evaluation of Medical Devices - Part 7:Ethylene Oxide Sterilization Residuals - ReplacesAAMI ST29 and AAMI ST30; Cited as relevantguidance to FDA-recognized standard | |
| Summary ofSubstantialEquivalence | Based on the indications for use, technological characteristics, safety, aperformance testing, the subject Aspira* Peritoneal Drainage System nthe pre-determined requirements under 21 CFR 820.30, Design Controldemonstrates that the subject device is substantially equivalent to thepredicate device. |
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Bard Access Systems, Inc. Aspira* Peritoneal Drainage System Special 510(k) Premarket Notification
The subject device met all pre-determined acceptance criteria and demonstrated substantial equivalence as compared to the predicate device.
- Aspira is the trademark and/or registered trademark of C.R. Bard, Inc. or an affiliate.
§ 876.5630 Peritoneal dialysis system and accessories.
(a)
Identification. (1) A peritoneal dialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions, and that consists of a peritoneal access device, an administration set for peritoneal dialysis, a source of dialysate, and, in some cases, a water purification mechanism. After the dialysate is instilled into the patient's peritoneal cavity, it is allowed to dwell there so that undesirable substances from the patient's blood pass through the lining membrane of the peritoneal cavity into this dialysate. These substances are then removed when the dialysate is drained from the patient. The peritoneal dialysis system may regulate and monitor the dialysate temperature, volume, and delivery rate together with the time course of each cycle of filling, dwell time, and draining of the peritoneal cavity or manual controls may be used. This generic device includes the semiautomatic and the automatic peritoneal delivery system.(2) The peritoneal access device is a flexible tube that is implanted through the abdominal wall into the peritoneal cavity and that may have attached cuffs to provide anchoring and a skin seal. The device is either a single use peritioneal catheter, intended to remain in the peritoneal cavity for less than 30 days, or a long term peritoneal catheter. Accessories include stylets and trocars to aid in the insertion of the catheter and an obturator to maintain the patency of the surgical fistula in the abdominal wall between treatments.
(3) The disposable administration set for peritoneal dialysis consists of tubing, an optional reservoir bag, and appropriate connectors. It may include a peritoneal dialysate filter to trap and remove contaminating particles.
(4) The source of dialysate may be sterile prepackaged dialysate (for semiautomatic peritoneal dialysate delivery systems or “cycler systems”) or dialysate prepared from dialysate concentrate and sterile purified water (for automatic peritoneal dialysate delivery systems or “reverse osmosis” systems). Prepackaged dialysate intended for use with either of the peritoneal dialysate delivery systems is regulated by FDA as a drug.
(b)
Classification. Class II (special controls). The following accessories are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9: A catheter finger grip that is non-patient contacting and intended for single use with a peritoneal catheter; a continuous ambulatory peritoneal dialysis (CAPD) belt; and a catheter stand that does not include weigh scales.