(64 days)
No
The summary does not mention AI, ML, or related terms, and the device description focuses on a balloon catheter for dilation.
Yes
The device is indicated for use to dilate esophageal strictures due to various underlying causes, which is a therapeutic action.
No
The device is indicated for use to dilate esophageal strictures, which is a therapeutic rather than a diagnostic function. While it is used with the EndoFLIP® system, which can provide measurements, the primary function of the EsoFLIP® ES balloon catheter itself is dilation.
No
The device description explicitly states it is a catheter and part of a system that utilizes a catheter, indicating a physical hardware component. The performance studies also focus on bench testing of the physical catheter.
Based on the provided information, the EsoFLIP® ES balloon catheter is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to dilate esophageal strictures. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is described as an endoscopically placed catheter used with a system. This further reinforces its nature as a device used for a procedure within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
IVDs are typically used to analyze samples in vitro (in glass, or outside the body) to provide diagnostic information. The EsoFLIP® ES is used in vivo (within the body) for a therapeutic purpose (dilation).
N/A
Intended Use / Indications for Use
The EsoFLIP® ES balloon catheter is indicated for use to dilate esophageal strictures due to esophageal surgery, primary gastro-esophageal reflux and radiation therapy.
Note: The EsoFLIP® ES catheter is to be used only with the EndoFLIP® system.
Product codes (comma separated list FDA assigned to the subject device)
PIE
Device Description
The EndoFLIP® system is an endoscopically placed device that utilizes a catheter for various indications. Crospon submitted and received 510(k) clearances for the EndoFLIP® System with a number of different catheters with different indications for use. This submission is seeking to expand the indication for use for the proposed EsoFLIP® ES catheter to dilate esophageal strictures due to esophageal surgery, primary gastro-esophageal reflux and radiation therapy.
In all cases the catheters are to only be used with the EndoFLIP® system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Esophageal / gastro-esophageal junction
Indicated Patient Age Range
Adult and adolescent patients
Intended User / Care Setting
Hospitals and Surgery Centers
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)
Bench Testing - We performed bench testing to demonstrate that the EsoFLIP® ES balloon dilation catheter will perform within specification.
- DHF 1473 EsoFLIP® Accuracy Test ●
- DHF 1296 EsoFLIP® Dilation Catheter Bonds Test ●
- DHF 1475 EsoFLIP® Balloon Fatigue Test ●
- DHF 1338 EsoFLIP® Catheter Torque Tests
- DHF 1454 EsoFLIP® Balloon Burst Test
- DHF 1471 EsoFLIP® Catheter Balloon Compliance ●
- DHF 1469 EsoFLIP® Catheter Assembly Tests
- DHF 1514 EsoFLIP® 2 Year Shelf Life Test
The results demonstrate that the EsoFLIP® ES has met the performance specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Measurement Range: 8 to 20 mm
Resolution: 0.1 mm.
Accuracy: ± 1mm (at 95% confidence) rounded to nearest integer.
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.
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.
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
§ 876.5980 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol features a stylized caduceus, which is a staff with two snakes entwined around it, often associated with medicine and healthcare.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 25, 2014
CROSPON, LTD. % Paul Dryden Consultant ProMedic, Inc. 24301 Woodsage Drive Bonita Springs, Florida 34134
Re: K142000
Trade/Device Name: ESOFLIP ES Regulation Number: 21 CFR 876.5980 Regulation Name: Esophageal Dilator With Balloon And Electrode Sensors Regulatory Class: Class II Product Code: PIE Dated: July 22, 2014 Received: July 23, 2014
Dear Paul Dryden,
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. 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
1
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" (21 CFR 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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Benjamin Fisher Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
2
| 510(k) Summary
| Page 1 of 5 | |
|---|---|
| Date Prepared | 24-Sep-14 |
| Company | Crospon Ltd. |
| Galway Business Park | |
| Dangan | |
| Galway, Ireland | |
| Tel - 011 [353] (91) 519882 | |
| Fax - 011 [353] (91) 519873 | |
| Official Contact: | John O'Dea PhD |
| Proprietary or Trade Name: | EsoFLIP® ES Balloon Dilation Catheter |
| Common/Usual Name: | Esophageal Dilator |
| Classification / CFR: | PIE / CFR 876.5980 / Class 2 |
| Device: | EsoFLIP® ES Balloon Dilation Catheter |
| Predicate Devices: | K983373 – B. Braun Impact Balloon Dilation Catheter |
| K132337 - Crospon - EsoFLIP® Catheter |
Device Description:
The EndoFLIP® system is an endoscopically placed device that utilizes a catheter for various indications. Crospon submitted and received 510(k) clearances for the EndoFLIP® System with a number of different catheters with different indications for use. This submission is seeking to expand the indication for use for the proposed EsoFLIP® ES catheter to dilate esophageal strictures due to esophageal surgery, primary gastro-esophageal reflux and radiation therapy.
In all cases the catheters are to only be used with the EndoFLIP® system.
Modifications of these devices vs. Predicates:
The following is a summary of the differences between the proposed EsoFLIP® ES and the predicate Crospon EsoFLIP® ES-330 catheter, cleared under K132337.
- (1) Expanded indications for use
- (2) Change of the balloon material to a stiffer material for the increased inflation pressure to 2 ATM.
- (3) Has diameter measurements at 16 points vs. the ES-330 (K132337) at 14 points
Indications for Use:
The EsoFLIP® ES balloon catheter is indicated for use to dilate esophageal strictures due to esophageal surgery, primary gastro-esophageal reflux and radiation therapy.
Note: The EsoFLIP® ES catheter is to be used only with the EndoFLIP® system.
3
510(k) Summary
Page 2 of 5 24-Sep-14
| Patient Population: | Patient population is patients with strictures. |
|---|---|
| Environment of Use: | Hospitals and Surgery Centers |
Contraindications:
The EsoFLIP® ES dilation catheter is contraindicated where:
- (1) endoscopy is contraindicated,
- (2) with actively bleeding varices and
- (3) for diameter measurements smaller than 8 mm or greater than 20 mm
Predicate Device Comparison:
Table 1 compares the EsoFLIP® ES Balloon Dilation catheter to the predicate Crospon EsoFLIP® ES-330 (K132337) and the B. Braun Impact Balloon Dilation Catheter (K983373).
The EsoFLIP® ES dilation catheter is viewed as substantially equivalent to the predicates B. Braun Impact Balloon Dilation Catheter (K983373) and the EsoFLIP® ES-330 catheter K132337 because:
Indications – The dilation indications for use are identical to the B/ Braun Impact Balloon Dilation catheter (K983373).
Discussion - The indications for use are identical to the dilation predicate. B. Braun Impact Balloon Dilation Catheter (K983373).
Technology - The EsoFLIP® Dest measurement technology, construction, and design are unchanged from the EsoFLIP® ES-330 catheter, K132337, when used with the EndoFLIP® system, K120997.
Discussion - The technology is unchanged from the Degr measurement predicate, EndoFLIP® -K120997. The proposed EsoFLIP® ES catheter measures diameter at 16 points, like the predicate K130906, which is 2 more than the predicate ES-330 (K132337) which has 14 points.
The dilation technology of the EsoFLIP® ES catheter: maximum diameter and balloon working length, together with its use with a guidewire, is identical to the dilation predicate B. Braun Impact Balloon Dilation Catheter (K983373).
Environment of Use - The environments of use - hospital and surgery centers - are identical to the predicates.
Discussion - The environments of use are identical to the predicate B. Braun Impact Balloon Dilation Catheter (K983373) and the EsoFLIP® ES-330 (K132337).
4
510(k) Summary Page 3 of 5 24-Sep-14
Patient Population - The patient populations are identical, specifically indicated for patients requiring dilation of esophageal strictures.
Discussion - The patient population is unchanged and identical to the predicate B. Braun Impact Balloon Dilation Catheter (K983373).
Non-clinical Testing Summary -
Bench Testing - We performed bench testing to demonstrate that the EsoFLIP® ES balloon dilation catheter will perform within specification.
- DHF 1473 EsoFLIP® Accuracy Test ●
- DHF 1296 EsoFLIP® Dilation Catheter Bonds Test ●
- DHF 1475 EsoFLIP® Balloon Fatigue Test ●
- DHF 1338 EsoFLIP® Catheter Torque Tests
- DHF 1454 EsoFLIP® Balloon Burst Test
- DHF 1471 EsoFLIP® Catheter Balloon Compliance ●
- DHF 1469 EsoFLIP® Catheter Assembly Tests
- DHF 1514 EsoFLIP® 2 Year Shelf Life Test
The results demonstrate that the EsoFLIP® ES has met the performance specifications.
Materials -
The materials in contact with the patient are identical to the predicates, EsoFLIP® ES-330 (K132337) and balloon materials has been tested per ISO 10993-1.
In accordance with G95-1 and ISO 10993-1 the catheters are considered as
- . Surface Contacting
- Mucosal membrane
- Limited duration ( The EsoFLIP® ES balloon catheter is indicated for use to dilate esophageal strictures due to esophageal surgery, primary gastro-esophageal reflux, radiation therapy.
Note: The EsoFLIP® ES catheter is to be used only with the EndoFLIP® system.
| Type of Use (Select one or both, as applicable): | |
|---|---|
| -------------------------------------------------- | -- |
XX Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (9/13)
Page 1 of 1
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