(82 days)
Not Found
No
The summary describes a balloon catheter for dilatation and does not mention any AI or ML components or functionalities.
Yes
The device is recommended for the dilatation of stenosis in the biliary and gastrointestinal tracts, which is a therapeutic intervention aimed at treating medical conditions.
No
The device is a balloon catheter used for dilatation of the biliary and gastrointestinal tracts, which is a therapeutic intervention, not a diagnostic one.
No
The device description and intended use clearly describe a physical balloon catheter, which is a hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for dilatation of the biliary and gastrointestinal tracts. This is a therapeutic procedure performed directly on the patient's body.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Lack of IVD Characteristics: The description doesn't mention any analysis of biological samples, chemical reactions, or diagnostic testing performed on specimens outside the body.
Therefore, the Modified Olbert® Balloon Catheter is a medical device used for a therapeutic intervention, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Modified Olbert@ Balloon Catheter products are recommended for biliary tract stenosis/sphincter stenosis and gastrointestinal tract dilatation through a flexible endoscope. The recommended application is printed on the label.
Product codes (comma separated list FDA assigned to the subject device)
FGE, KNO
Device Description
Boston Scientific Corporation believes that the Modified Olbert® Balloon Catheter is substantially equivalent to the currently-marketed predicate devices. Table 9-1 compares the descriptive characteristics of these products.
| T ABLE 9-1: COMPARISON OF MODIFIED OLBERT® BALLOON CATHETER TO PREDICATE DEVICES |
|---|
| Modified Olbert® Balloon Catheter (This 510(k)) |
| ------------ |
| Indication |
| BALLOON |
| Diameter |
| Length |
| Maximum Recommended Pressure |
| Material |
| CATHETER SHAFT |
| Length |
| Diameter |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
biliary tract, gastrointestinal tract
Indicated Patient Age Range
Not Found
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)
Laboratory testing regarding characteristics was performed on Modified Olbert@ Balloon Catheter to verify its safety and performance. A biocompatibility assessment was performed on the patient- and fluidcontact materials of the Modified Olbert® Balloon Catherer with satisfactory results.
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.
K934411, K945576, K952887, K851647, K961438
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.
Not Found
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
§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
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SECTION 9 510(K) SUMMARY
NOV 1 0 1997
FOI RELEASABLE
Pursuant to § 13(1)(3)(A) of the Food, Drug, and Cosmetic Act, Boston Scientific Corporation is required Pursualit to your results of the result, Dreg, and secures.
to submit with this Premarket Notification " ...dequate summary of any information respecting setty and to submit with this frometion will be made available upon request of any person." Boston encentific Corporation chooses to submit a summary of information respecting safety and effectiveness.
| > Common/Usual Names: | Balloon Catheter | ||
|---|---|---|---|
| > TRADE/PROPRIETARY NAME: | Olbert Balloon Catheter System®, NoProfile® Olbert Balloon | ||
| Catheter System® | |||
| > Classification Name & | |||
| DEVICE CLASSIFICATION: | Class II | ||
| Name | Number | 21 CFR Ref. | |
| Esophageal Dilator | |||
| Endoscope & Accessories | 78 KNQ | ||
| 78 KOG | 876.5365 | ||
| 878.1500 | |||
| > DEVICE PANEL/BRANCH: | Gastroenterology-Urology (GU) | ||
| Gastro-Renal (GRDB) | |||
| > Owner/Operator: | Boston Scientific Corporation | ||
| One Boston Scientific Place | |||
| Natick, MA 01760 | |||
| Owner/Operator No. 9912058 | |||
| > Contact Person: | Daniel J. Dillon, Senior Regulatory Affairs Specialist |
INDICATIONS FOR USE
The Modified Olbert@ Balloon Catheter products are recommended for biliary tract stenosis/sphincter Inc Mounted Cloud Collection through a flexible endoscope. The recommended application is printed on the label.
CONTRAINDICATIONS
Not recommended for cascs in which the bile duct has been surgically intervened, a stricture which is totally impassable, or for dilatation of strictures due to external mechanical obstruction, i.e., suure and metallic clips.
1
POTENTIAL COMPLICATIONS
Potential complications with biliary tract dilation include incre-hepatic damage, transient bleeding, post-operative cholangitis, and stricture of a primary hepatic duct. Potential complication from GI tract dilation include, but may not be limited to perforation , hemorthage, hematoma, septicemia./infection, allergic reaction to contrast medium.
DESCRIPTIVE AND TECHNOLOGICAL CHARACTERISTICS OF PROPOSED AND PREDICATE DEVICES
Boston Scientific Corporation believes that the Modified Olbert® Balloon Catheter is substantially equivalent to the currently-marketed predicate devices. Table 9-1 compares the descriptive characteristics of these products.
PERFORMANCE CHARACTERISTICS
Laboratory testing regarding characteristics was performed on Modified Olbert@ Balloon Catheter to verify its safety and performance. A biocompatibility assessment was performed on the patient- and fluidcontact materials of the Modified Olbert® Balloon Catherer with satisfactory results.
PACKAGING, STERILIZATION, AND PYROGENICITY
The Modified Olbert® Balloon Catheter will be packaged a styrene/butadiene copolymer (SBS) tray with a Tyvek lid and a Tyvek outer pouch. The Modified Olbert® Balloon Catheter will be sterilized using ryvek no and a 1 your of your procol for ethylene oxide sterilization. Pyrogenicity testing will be performed on a periodic basis to monitor bacterial endotoxin levels.
CONCLUSION
Boston Scientific Corporation believes that Modified Olbert® Balloon Catherer is substantially equivalent Doston Belonal o Ocedicate devices. Table 9-1 compares the descriptive characteristics of these to the carrently manologies in Table 9-1, the Modified Olbert® Balloon Catherer is equivalent in its indications for use, while being very similar in design and materials. In addition, Boston Scientific metemons for are, and biocompatibility information. The information. The information presented provides assurance that the Modified Obert® Balloon Catheter will meet the minimum requirements that are considered acceptable for its intended use.
2
| T ABLE 9-1: COMPARISON OF MODIFIED OLBERT® BALLOON CATHETER TO PREDICATE DEVICES |
|---|
| Modified Olbert®
Balloon Catheter
(This 510(k)) | NoProfile® with
Modified End Connector
(510(k) No. K934411) | Modified NoProfile®
(510(k) No. K945576) | NoProfile® with
Vectran Fibers
(510(k) No. K952887) | Olbert Balloon Catheter
for Biliary Dilatation
(510(k) No. K851647) | Vector TTS™ Balloon
Dilatation Catheter
(510(k) No. K961438) |
| ------------------------------------------------------- | ------------------------------------------------------------------- | --------------------------------------------- | ----------------------------------------------------------- | --------------------------------------------------------------------------- | -------------------------------------------------------------------- |
|---|
| USE | ||||||
|---|---|---|---|---|---|---|
| Indication | Dilatation of Biliary and | |||||
| Other Non-GI Strictures | «- Same | «- Same | «- Same | «- Same | Dilatation of GI | |
| Strictures |
| BALLOON | ||||||
|---|---|---|---|---|---|---|
| Diameter | 4-14 mm | 3-10 mm | 3-10 mm | 3-12 mm | 4-14 mm | 6-25 mm |
| Length | 2.5-4.0 cm | 2.0-4.0 cm | 2-10 cm | 2-10 cm | 2.5-4.0 cm | 5.5-8.0 cm |
| Maximum | ||||||
| Recommended | ||||||
| Pressure | 9-12 atm | 10-12 atm | 10-12 atm | 12 atm | 9-12 atm | 2-6 atm |
| Material | Polyurethane | «- Same | «- Same | «- Same | «- Same | Ethylene Vinyl |
| Acetate | ||||||
| CATHETER SHAFT | ||||||
| Length | 180 cm | 180 | 40-180 cm | 40-180 cm | 40-180 cm | 180-240 cm |
| Diameter | 5.8-7.8 Fr | 4.8-7.8 Fr | 4.8-7.8 Fr | 4.8-7.8 Fr | 6-7.5 Fr | 7 Fr., tapers to 5 Fr |
8
3
Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized image of an eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The text is in all capital letters.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 25, 2015
Boston Scientific Corporation Daniel J. Dillon Senior Regulatory Affairs Specialist One Boston Scientific Place Natick, MA 01760-1537
Re: K973113 Trade/Device Name: Olbert Balloon Catheter System® Regulation Number: 21 CFR§ 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE, KNO Dated (Date on orig SE Itr): August 18, 1997 Received (Date on orig SE Itr): August 20, 1997
Dear Daniel J. Dillon,
This letter corrects our substantially equivalent letter of November 10, 1997.
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
4
Page 2 -
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. 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 dovice 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 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. 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,
Joyce M. Whang -S
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
5
SECTION 1 INDICATIONS FOR USE
510(k) Number: K973113
Device Name: Modified Olbert® Balloon Catheter
Indication for Use:
The Modified Olbert@ Balloon Catheter products are recommended for biliary tract stenosis/sphincter stenosis and gastrointestinal tract dilatation through a flexible endoscope. The recommended application is printed on the label. *
- The recommended application on the label may refer to any combination of transpapillary, pyloric, colonic, anastomotic, and/or esophageal dilatation.
Robert Ratliff/
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number 73117
Prescription Use _ (Per 21 CFR 801.109)
Over-the-Counter Use_