(38 days)
The Boston Scientific Corporation Rigiflex™ II Single-Use Achalasia Balloon Dilator is indicated for dilatation of the cardia in patients with achalasia.
The Rigiflex™ II Single-Use Achalasia Balloon Dilator consists of a balloon, catheter shaft, distal tip and proximal end.
I am sorry, but based on the text provided, I cannot answer your request. The document is a 510(k) premarket notification for a medical device (Rigiflex™ II Single-Use Achalasia Balloon Dilator) and confirms its substantial equivalence to a predicate device. However, it does not contain the specific acceptance criteria, details of a study proving device performance against those criteria, sample sizes, expert qualifications, adjudication methods, or other elements you've requested.
The section "PERFORMANCE DATA" briefly mentions that "functional testing support a determination of substantial equivalence," but it does not elaborate on the data itself, the criteria it met, or the specifics of the study design. It also refers to a general FDA guidance document, not a report of specific study results for this device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002
October 9, 2014
Boston Scientific Corporation Endoscopy Division Paige Sweeney Senior Regulatory Affairs Specialist One Boston Scientific Place Natick, MA 01760-1537
- Re: K050232
Trade/Device Name: RigiflexTM II Single-Use Achalasia Balloon Dilator Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: PID Dated (Date on orig SE ltr): February 10, 2005 Received (Date on orig SE ltr): February 11, 2005
Dear Paige Sweeney,
This letter corrects our substantially equivalent letter of March 11, 2005.
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.
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Page 2 - Paige Sweeney
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 (OS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/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/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
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for
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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000024
Special 510(k) Premarket Notification Rigiflex™ II Single-Use Achalasia Balloon Dilator Boston Scientific Corporation January 31, 2005
INDICATIONS FOR USE STATEMENT
510(k) KOSO232 To be determined Number Device Name Rigiflex™ II Single-Use Achalasia Balloon Dilator Indications For Use The Boston Scientific Corporation Rigiflex™ II Single-Use Achalasia Balloon Dilator is indicated for dilatation of the cardia in patients with achalasia.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Per 21 CFR 801.109) OR
Over the Counter Use
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
..............................................................................................................................................................................
Nancy C. Brogdon
(Division S Division of Reproductive and Radiological Devic 510(k) Number
Proprietary and Confidential Information of Boston Scientific Corporation
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Boston Scientific Corporation January 31, 2005
510 (k) SUMMARY
| SPONSOR: | Boston Scientific CorporationOne Boston Scientific PlaceNatick, MA 01760 |
|---|---|
| CONTACT PERSON: | Paige K. SweeneySenior Regulatory Affairs Specialist |
| DEVICE: | |
| Trade Name:Common Name:Classification: | Rigiflex™ II Single-Use Achalasia Balloon DilatorBalloon Dilatation CatheterClass II, per 21 CFR Part 876, Section 5365 |
| PREDICATE DEVICE: | Boston Scientific Rigiflex™ Achalasia Balloon Dilator(K781772). |
| DESCRIPTION: | The Rigiflex™ II Single-Use Achalasia Balloon Dilatorconsists of a balloon, catheter shaft, distal tip andproximal end. |
| INTENDED USE: | The Boston Scientific Corporation Rigiflex™ II Single-Use Achalasia Balloon Dilator is indicated for dilatationof the cardia in patients with achalasia. |
| COMPARISON OFCHARACTERISTICS: | The modified device is substantially equivalent to thecurrently marketed device, as they have the sameoperating principal and intended use. In addition, theresults of design control activities do not raise any newissues of safety or effectiveness. |
| PERFORMANCE DATA: | FDA's "Guidance for the Content of PremarketNotifications", and the results of physical comparisonand functional testing support a determination ofsubstantial equivalence for the modified device whencompared to the predicate device. |
| The modified device is substantially equivalent to thecurrently marketed Boston Scientific Rigiflex™Achalasia Balloon Dilator in terms of performancecharacteristics, biocompatibility, and intended use. |
Proprietary and Confidential Information of Boston Scientific Corporation
§ 876.5980 Gastrointestinal tube and accessories.
(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.