(51 days)
Not Found
No
The device description and performance studies focus on the mechanical function of tubing and accessories for irrigation and insufflation, with no mention of AI or ML capabilities.
No
The device provides irrigation and insufflation during GI endoscopic procedures, which are supportive functions for the procedure rather than direct therapeutic actions on the patient's condition.
No
The device is intended to provide irrigation and supply air/CO2 during GI endoscopic procedures for therapeutic or procedural assistance, not for diagnosing a condition.
No
The device description explicitly states it is a "disposable, sterile device" and includes "tubing and accessories," indicating it is a physical hardware product, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for providing irrigation and supplying air/CO2 during GI endoscopic procedures. This is a procedural device used in vivo (within the body) during a medical procedure.
- Device Description: The description reinforces its use during GI endoscopic procedures and its function in delivering fluids and gases.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to obtain information about a physiological state, health, or disease. IVDs typically involve analyzing samples like blood, urine, tissue, etc.
Therefore, the Universal Irrigation Solution Hybrid™ is a medical device used during a procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Universal Irrigation Solution Hybrid™ (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via sterile water and to supply air (via an air pump) or CO2 (via aCO2 pump) along with sterile water during GI endoscopic procedures when used in conjunction with an irrigation pump or cautery unit.
Product codes (comma separated list FDA assigned to the subject device)
KOG, OCX
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
GI
Indicated Patient Age Range
Male/Female, Pediatric to Adult
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)
For irrigation, the 100605 Universal Irrigation Solution Hybrid™ meets or exceeds the performance of the predicate device, the 100130 EndoGator® with the 100115 Auxiliary Water Jet Connector. Thus, the 100605 Hybrid is an effective means of achieving irrigation in GI endoscopic procedures.
When using the 100605 Hybrid the insufflation air flow rate is comparable to that when using the 100145 SmartCap. The system will deliver enough air for insufflation in the time typically used for insufflation. Thus, the 100605 Hybrid is an effective means of achieving insufflation in GI endoscopic procedures.
The lens rinsing performance of the 100605 Hybrid provides a quicker delivery of a blast of water than the predicate 100145 SmartCap device and maintains a sufficient flow of water to rinse debris from the lens. Thus, the 100605 Hybrid is an effective means of achieving lens rinsing in Gl endoscopic procedures.
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.
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
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, 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 for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
Traditional 510(k) Submission Byrne Medical, Inc., Conroe, Texas 77303
Summary of Safety and Effectiveness Data
NOV 1 9 2010
Comparison of features and principles of operation between the Universal Irrigation Solution Hybrid™ and Predicate Devices, Byrne Medical EndoGator®System and Byrne Medical SmartCap® ( K092429 and K093665 respectively).
| Characteristic | Same | |||
|---|---|---|---|---|
| Trade Name | EndoGator® | Endo SmartCap® | Hybrid™ | N |
| Part No. | 100130 | 100145 | 100605 | N |
| 510(k) No. | K092429 | K093665 | N/A | N |
| Product Code | FEQ | KOG | KOG | N |
| Regulation | ||||
| Number | 876.1500 | 876.1500 | 876.1500 | Y |
| Class | II | II | II | Y |
| Advisory | ||||
| Committee | Gastroenterology/Urology | Gastroenterology/Urology | Gastroenterology/Urology | Y |
| Indications for | ||||
| use | The EndoGator® system | |||
| (tubing and accessories to | ||||
| accommodate various | ||||
| endoscopes and irrigation | ||||
| pumps) is intended to | ||||
| provide irrigation via sterile | ||||
| water during GI | ||||
| endoscopic procedures | ||||
| when used in conjunction | ||||
| with an irrigation pump or | ||||
| cautery unit. | The Endo SmartCap® | |||
| is intended to be used | ||||
| with an air or CO2 and/or | ||||
| pump along with a sterile | ||||
| water source to supply air | ||||
| or CO2 and sterile water | ||||
| to an endoscope during | ||||
| endoscopic procedures. | The Universal Irrigation | |||
| Solution Hybrid™ | ||||
| (tubing and accessories | ||||
| to accommodate various | ||||
| endoscopes and | ||||
| irrigation pumps) is | ||||
| intended to provide | ||||
| irrigation via sterile | ||||
| water and to supply air | ||||
| (via an air pump) or CO2 | ||||
| (via aCO2 pump) along | ||||
| with sterile water during | ||||
| GI endoscopic | ||||
| procedures when used | ||||
| in conjunction with an | ||||
| irrigation pump or | ||||
| cautery unit. | Combined | |||
| Sterile | Yes | Yes | Yes | Y |
| Single Use | Yes (24 hr.) | Yes (24 hr.) | Yes (24 hr.) | Y |
| Compatible | ||||
| Endoscope(s) | Olympus® | |||
| 140/160/180/240/260 series | ||||
| endoscopes | Olympus® | |||
| 140/160/180/240/260 | ||||
| series endoscopes | Olympus® | |||
| 140/160/180/240/260 | ||||
| series endoscopes | Y | |||
| Patient | ||||
| Population | Male/Female, Pediatric to | |||
| Adult | Male/Female Pediatric to | |||
| Adult | Male/Female, Pediatric | |||
| to Adult | Y | |||
| Reusable or | ||||
| disposable | Disposable | Disposable | Disposable | Y |
1
CONCLUSION:
For irrigation, the 100605 Universal Irrigation Solution Hybrid™ meets or exceeds the performance of the predicate device, the 100130 EndoGator® with the 100115 Auxiliary Water Jet Connector. Thus, the 100605 Hybrid is an effective means of achieving irrigation in GI endoscopic procedures.
When using the 100605 Hybrid the insufflation air flow rate is comparable to that when using the 100145 SmartCap. The system will deliver enough air for insufflation in the time typically used for insufflation. Thus, the 100605 Hybrid is an effective means of achieving insufflation in GI endoscopic procedures.
The lens rinsing performance of the 100605 Hybrid provides a quicker delivery of a blast of water than the predicate 100145 SmartCap device and maintains a sufficient flow of water to rinse debris from the lens. Thus, the 100605 Hybrid is an effective means of achieving lens rinsing in Gl endoscopic procedures.
Based on the data results generated with the comparative testing of the subject device compared to the two predicate devices, we have determined, the performance of the 100605 Universal Irrigation Solution Hybrid™is substantially equivalent to that of the combination of the 100145 Endo SmartCap® and 100130 EndoGator® with the 100115 Auxiliary Water Jet Connector.
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Image /page/2/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 lines representing its wings and body. The eagle is facing right. 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 Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. John Willis Director of Regulatory Affairs Byrne Medical, Inc. 3150 Pollok Drive CONROE TX 77303
NOV . 1 9 . 2010
Re: K102855
Trade/Device Name: Universal Irrigation Solution Hybrid™ Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: OCX Dated: September 28, 2010 Received: September 29, 2010
Dear Mr. Willis:
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 w 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 of medical device-related
3
Page 2
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.
Huker Lemur MD
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive. Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use 102855
NOV 1 9 2010
510(k) Number (if known)
Device Name: Universal Irrigation Solution Hybrid™ Indications for Use:
The Universal Irrigation Solution Hybrid™ (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via sterile water and to supply air (via an air pump) or CO2 (via aCO2 pump) along with sterile water during GI endoscopic procedures when used in conjunction with an irrigation pump or cautery unit.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hebert Lum
Division Sigh-Off) Division Sign-On )
Division of Reproductive, Gastro-Renal, and Irological Devices 510(k) Number
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Section 6