(61 days)
The DEFENDO™ Disposable Suction Valve is intended to be used to control the suction function on an endoscope during a GI endoscopic procedure.
The DEFENDO™ Disposable Suction Valve is a disposable device that attaches to the suction cylinder of an endoscope. When the valve is depressed, the suction function on the endoscope is activated, allowing for the suctioning of fluid through the stem of the valve where it flows into the Suction Pump Canister.
Here's a breakdown of the acceptance criteria and the study details for the DEFENDO™ Disposable Suction Valve, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|
| Connection to the endoscope: The valve must connect to the endoscope by aligning valve with port and pressing down. Must not be cumbersome to attach. | The force required to connect the BMI suction valve (100305) and the ease of installation was similar to the predicate (Olympus® MH-443). Alignment with the port notches was comparable. Test results showed "Smooth" for all 10 tests of the BMI 100305, matching the "Smooth" results of the predicate. | Pass |
| Priming time to Suction Canister: The device must be comparable to the predicate device in terms of being able to supply water within a reasonable time frame (priming time). | The average priming time for the BMI 100305 was 3.92 seconds (SD 0.163) over 10 tests, compared to the predicate's average of 4.16 seconds (SD 0.147) over 8 tests. The results indicate no significant difference between the two units. | Pass |
| Material Quantity Removed: The device must be comparable to the predicate device in terms of the amount of water removed in the defined time frame. | The average material removed for the BMI Suction Valve was 512.2 grams (SD 11.25) over 8 samples (10 tests each), compared to the predicate's average of 528.5 grams (SD 13.61) over 8 samples (10 tests each). The difference was < 4.5% for the worst case view (30 seconds of suction) and < 3.3% for a more typical 5-10 second suction. The BMI unit also showed improved repeatability (lower SD). | Pass |
| Spring Force & Displacement: The device must be comparable to the predicate device in terms of force required to activate the button. | The average force for the BMI 100305 was 2.862 lb (SD 0.178) for an average displacement of 0.1962 in (SD 0.003). The predicate averaged 2.0813 lb (SD 0.086) for an average displacement of 0.1876 in (SD 0.005). While there was a "slight difference," these differences were not perceivable in blind tests by the tester or other selected parties (3 additional people). | Pass |
| No sharp edges: The device must not be capable of snagging or piercing a nitrile glove if the wearer rubs his or her gloved fingers over any surface of the device. | Testing showed that the BMI Suction valve does not pinch, cut, or tear nitrile gloves. All 10 tests for the BMI 100305 resulted in "Pass," matching the "Pass" results of the predicate. | Pass |
2. Sample Size Used for the Test Set and Data Provenance
- Connection to Endoscope: 10 tests for BMI 100305, 10 tests for Olympus MH-443 (predicate).
- Priming Time: 10 tests for BMI 100305, 8 tests for Olympus MH-443 (predicate).
- Material Quantity Removed: 8 devices of BMI-215 (DEFENDO™) and 8 devices of Olympus MH-443 (predicate), each subjected to 10 suction tests. This totals 80 tests for each device type.
- Spring Force & Displacement: 10 tests for BMI 100305, 8 tests for Olympus MH-443 (predicate).
- Sharp Edges: 10 tests for BMI 100305, 8 tests for Olympus MH-443 (predicate).
Data Provenance: The study appears to be a prospective bench testing study conducted by Byrne Medical, Inc. The document does not specify the country of origin for the data generation, though Byrne Medical Inc. is based in Conroe, TX, USA. The predicate device, Olympus® MH-443, is manufactured by Olympus® Optical Co. Ltd. Tokyo, Japan.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: For the "Spring Force & Displacement" test, it's mentioned that the differences were not perceivable in "blind tests by the tester or other selected parties (3 additional people)". This suggests 4 individuals participated in evaluating the tactile perception of force.
- Qualifications of Experts: The qualifications of these individuals are not specified in the provided document. For the "Sharp Edges" test, a "tester's hand" is mentioned, implying at least one individual performed the test, again with no specific qualification mentioned.
4. Adjudication Method for the Test Set
The document does not explicitly describe a formal adjudication method (like 2+1 or 3+1 consensus). The evaluation criteria for most tests (e.g., connection, priming time, material quantity, sharp edges) relied on quantitative measurements or direct observation against the predicate device. For the "Spring Force & Displacement" test, a "blind test" by multiple individuals was mentioned, suggesting a qualitative comparison, but without a formal consensus or adjudication process detailed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This study is a bench testing evaluation of a physical medical device (a suction valve), not an AI-powered diagnostic or imaging tool. Therefore, the concept of "human readers improving with AI vs without AI assistance" is not applicable here.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical medical device (a disposable suction valve) and does not involve an algorithm or AI.
7. The Type of Ground Truth Used
The "ground truth" for these tests was established by:
- Quantitative Benchmarking: Direct measurements and comparisons against a legally marketed predicate device (Olympus® MH-443 Suction Valve).
- Physical Observation/Assessment: Direct observation of ease of connection, absence of sharp edges, and tactile perception (for spring force).
- The "truth" was based on whether the performance characteristics of the new device were "comparable" or "substantially equivalent" to the predicate, as defined by the acceptance criteria.
8. The Sample Size for the Training Set
This is not applicable as the device is a physical medical device and does not involve machine learning algorithms that require a training set.
9. How the Ground Truth for the Training Set was Established
This is not applicable for the same reason as above (no training set for a physical device).
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Image /page/0/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, which is a common symbol of the United States.
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 Dr. CONROE TX 77303
NOV - 8 2010
Re: K102581
Trade/Device Name: DEFENDO™ Disposable Suction Valve for G1 Endoscopes Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: ODC, FDF Dated: September 7, 2010 Received: September 9, 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. Ilisting 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 of medical device-related
{1}------------------------------------------------
Page 2
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 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.him 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.
Hushut Lemur, MD
lerbert 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
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Traditional 510(k) Submission Byrne Medical, Inc., Conroe, Texas 77303
Indications for Use
510(k) Number (if known)
Device Name: DEFENDO™ Disposable Suction Vaļve for GI Endoscopes
Indications for Use:
The DEFENDO™ Disposable Suction Valve is intended to be used to control the suction function on an endoscope during a GI endoscopic procedure.
Prescription Use X (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 Lemon
Page 1 of 1
sion Sian-Off on of Reproductive. Gastro-Ren 510(k) Number
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510(k) Summary of Safety and Effectiveness Data
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{4}------------------------------------------------
Summary of Safety and Effectiveness Data
The Byrne Medical, Inc., DEFENDO™ Disposable Suction Valve and predicate device (Olympus® MH-443 Suction Valve, K001241) are in Class II, 21 CFR 876.1500 with Advisory Committee of Gastroenterology/Urology.
The predicate device Olympus® - Suction Valve (K001241) is manufactured by Olympus® Optical Co. Ltd. Tokyo, Japan.
The Byrne Medical, Inc., DEFENDO™ Disposable Suction Valve has been determined to meet the equivalence decision making process as detailed by the "510(k) Substantial Equivalence Decision-Making Process Flowchart".
| Characteristic | Byrne Medical | Olympus® | Same? |
|---|---|---|---|
| Part number | 100305 | MH-443 | N/A |
| Trade Name | 100305 DEFENDO™Disposable Suction Valve | Olympus® EVIS EXERAColonovideoscopes | N/A |
| 510(k) Doc. Number | This submission | K001241 | N/A |
| Product Code | KOG | FDF | No |
| Regulation Number | 876.1500 | 876.1500 | Yes |
| Class | II | II | Yes |
| Review AdvisoryCommittee | Gastroenterology/Urology | Gastroenterology/Urology | Yes |
| Indications for use | The DEFENDO™ DisposableSuction Valve is intended tobe used to control theSuction function on anendoscope during a GIendoscopic procedure. | The Olympus® Suction valveis intended to be used tocontrol the Suction functionon an Olympus ®endoscopeduring a GI endoscopicprocedure. | Yes |
| Sterile | Yes | No, user must sterilize | No |
| Single Use | Yes | No, re-sterilize, re-use | No |
| CompatibleEndoscope(s) | Olympus®140/160/180/240/260 seriesendoscopes | Olympus®140/160/180/240/260 seriesendoscopes | Yes |
| Patient Population | Male/Female, Pediatric toAdult | Male/Female Pediatric toAdult | Yes |
| Reusable ordisposable | Disposable | Reusable | No |
Table 14-1: Comparison of features and principles of operation between the DEFENDO™ Disposable Suction Valve and Predicate Device (Olympus®MH-443 Suction Valve, K001241)
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Testing:
The DEFENDO™ Disposable Suction Valve testing was conducted under FDA recognized standards.
Similarities and Differences:
Indications for Use
Both products are attached to the Suction cylinder of the endoscope. When the valve is depressed, suction function on the endoscope is activated allowing for the suctioning of fluid through the stem of the valve where it flows into the Suction Pump Canister.
The DEFENDO™Disposable Suction Valve and its predicate have the same regulation number and class, the same patient population and environment of use.
Neither the predicate nor the Byrne Suction valve come in direct contact with the patient. Fluid flow is one way, away from patient..
Comparative Testing
Bench testing for the 100305 Suction Valve
Background:
Bench testing is performed to confirm that the disposable BMP-215 DEFENDO™ Disposable Suction Valve is equivalent to the predicate Olympus® MH-443 Suction Valve. Accontance criteria.
| Acceptance criteria: | |
|---|---|
| Connection tothe endoscope | The valve must connect to the endoscope by aligning valve with portand pressing down. Must not be cumbersome to attach. |
| Priming time toSuctionCanister | The device must be comparable to the predicate device in terms ofbeing able to supply water within a reasonable time frame (primingtime). |
| MaterialQuantityRemoved | The device must be comparable to the predicate device in terms of theamount of water removed in the defined time frame. |
| Spring Force &Displacement | The device must be comparable to the predicate device in terms offorce required to activate the button. |
| No sharpedges | The device must not be capable of snagging or piercing a nitrile gloveif the wearer rubs his or her gloved fingers over any surface of thedevice. |
Sq.
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| Materials and Equipment | |
|---|---|
| Olympus® 160 series endoscope | Nitrile Glove |
| Olympus® MH-443 Suction Valve | Stopwatch |
| Byrne Medical BMP-215 Suction Valve | Endo SmartCap |
| IMADA Force Gage | Olympus Suction Pump |
| Water Basin with water | Scale |
| Suction Tube for Suction Pump |
-
- To test connection to the endoscope: Aligned BMI suction valve with port and pressed down. Recorded observations on the ease of use as compared to predicate.
-
- To test for priming time: Test set-up replicated a tvpical Gl system for procedures by attaching the suction valve into the port and using a sterile water bottle with a new SmartCap. Placed the distal tip in a water bath. Turned the suction pump on, set the stop watch to 0. Then depressed the suction button and quantify the time it takes for the water to travel from the distal tip of the endoscope to the suction canister.
-
- To test for material quantity removed: Drained water from scope and removed water from suction canister, weighed empty canister and zeroed scale, returned canister to suction pump and replaced cap on canister, inserted endoscope into water basin. turned suction pump on, set stop watch to 0, depressed suction valve firmly with finger over the complete button head and held for 30 seconds. At the end of the 30 seconds, removed finger from button, removed canister from suction pump and weighed the amount of net water suctioned through the scope. Determined if the predicate and the disposable have comparable material quantity removal.
-
- To test for spring force: Attached the suction valve into the port and fixtured the port channel under the IMADA force gage. Used a flat attachment on the force gage to be able to depress the suction valve. Recorded the force/ displacement readings to create a curve.
-
- To test for sharp edges: Placed nitrile gloves on tester's hand and attached the suction valve to the port. Touched every part of valve, especially the spring area. Recorded observations on snagging or ripping of glove.
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-
- To test connection to the endoscope: Align BMI suction valve with port notches and press down. Record observations on the ease of use.
-
- To test for priming time: Test set-up replicated a typical Gl system for procedures by attaching the suction valve into the port and the suction line to the suction pump. Place the distal tip in a water bath. Turn the suction pump on and set the stop watch to 0. Then depress the suction button and quantify the time it takes for the water to travel from the distal tip of the endoscope to the suction canister.
-
- To test for material quantity removed: Drain water from the scope and remove water from the suction canister, weigh empty canister and zero scale, return canister to suction pump and replace cap on canister, insert endoscope into water basin, turn suction pump on, set stop watch to 0, depress suction valve firmly with finger over the complete button head and hold for 30 seconds. At the end of the 30 seconds, remove finger from button, remove canister from suction pump and weigh the amount of net water suctioned through the scope. Determine if the oredicate and the disposable have comparable material quantity removal.
- To test for spring force and displacement: Attach the suction valve into the port and 9. fixture the endoscope body under the IMADA force gage. Use a flat attachment on the force gage to be able to depress the suction valve. Record the force and displacement readings to compare products.
-
- To test for sharp edges: Tester is to put on nitrile gloves and attach the suction valve to the port. Ask tester to touch every part of valve, especially the spring area. Record observations on snagging or ripping of glove.
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. ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------
res
Results:
- Connection to the endoscope
| Olympus (predicate) | BMI 100305 |
|---|---|
| Smooth | Smooth |
| Smooth | Smooth |
| Smooth | Smooth |
| Smooth | Smooth |
| Smooth | Smooth |
| Smooth | Smooth |
| Smooth | Smooth |
| Smooth | Smooth |
| Smooth | Smooth |
| Average | Average |
| Smooth | Smooth |
Result: Pass
The force required to connect the BMI suction valve (100305) and the ease of installation was similar to the predicate (Olympus® MH-443). Alignment with the port notches was comparable. Test results verify that the BMI suction valve (100305) is substantially equivalent to the predicate device.
62
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2. Priming time:
| Olympus (predicate) | BMI 100305 |
|---|---|
| 4.19 | 3.97 |
| 4.19 | 3.93 |
| 4.21 | 4.13 |
| 4.32 | 4.09 |
| 4.19 | 4.00 |
| 3.82 | 3.71 |
| 4.21 | 3.59 |
| 4.12 | 3.97 |
| 3.91 | |
| 3.97 | |
| Average | Average |
| 4.16 | 3.92 |
| StandardDeviation | StandardDeviation |
| 0.147 | 0.163 |
Result: Pass
The test was performed to establish the time that the water took to travel from the water reservoir to the distal tip of the endoscope. The results indicate that there is no significant difference between the two units. The BMI suction valve is substantially equivalent to the predicate (MH-443).
65
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3. To test for material quantity removed
Eight BMP-215 and eight MH-443 Suction Valves were tested for suction ability by placing an endoscope into a filled water basin. Suction Valves were depressed with finger over hole in valve head and suction was performed for thirty seconds ten times each for each of the eight valves. The results are presented below:
| Olympus MH-443 Suction Valve | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Sample | |||||||||
| Test | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | |
| MaterialRemovedIn Grams | 1 | 534.4 | 541.2 | 540.0 | 545.4 | 544.5 | 540.8 | 543.3 | 545.7 |
| 2 | 533.3 | 537.5 | 522.8 | 523.7 | 525.8 | 516.3 | 510.0 | 515.3 | |
| 3 | 539.6 | 552.7 | 531.6 | 522.9 | 521.3 | 513.6 | 509.8 | 513.0 | |
| 4 | 553.1 | 545.1 | 540.0 | 520.5 | 523.2 | 515.1 | 513.3 | 509.6 | |
| 5 | 554.4 | 541.8 | 522.8 | 527.2 | 532.0 | 517.8 | 514.2 | 511.0 | |
| 6 | 556.4 | 539.1 | 531.6 | 524.0 | 529.4 | 516.8 | 511.1 | 512.8 | |
| 7 | 551.1 | 548.0 | 540.0 | 534.7 | 524.2 | 520.0 | 520.6 | 510.1 | |
| 8 | 553.5 | 534.3 | 522.8 | 524.2 | 517.7 | 515.6 | 517.1 | 522.5 | |
| 9 | 550.3 | 544.5 | 531.6 | 529.8 | 507.9 | 527.0 | 520.8 | 529.3 | |
| 10 | 546.8 | 527.9 | 540.0 | 536.5 | 513.2 | 515.4 | 505.7 | 512.4 | |
| Average | 547.3 | 541.2 | 532.3 | 528.9 | 523.9 | 519.8 | 516.6 | 518.2 | |
| Grand Average | 528.5 | ||||||||
| Standard Deviation | 13.61 |
િત્ર
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Traditional 510(k) Submission
| Byrne Medical Suction Valve | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sample | |||||||||||||||||
| Test | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | |||||||||
| MaterialRemovedin Grams | 1 | 540.5 | 536.9 | 535.7 | 533.2 | 538.8 | 535.8 | 542.0 | 539.5 | ||||||||
| 2 | 511.6 | 505.4 | 509.8 | 514.9 | 510.9 | 518.5 | 507.7 | 506.2 | |||||||||
| 3 | 501.6 | 508.2 | 507.8 | 504.8 | 520.3 | 505.5 | 503.1 | 509.2 | |||||||||
| 4 | 520.4 | 515.4 | 511.2 | 507.1 | 520.3 | 524.9 | 499.6 | 509.3 | |||||||||
| 5 | 517.4 | 508.0 | 510.0 | 511.4 | 515.9 | 506.0 | 504.2 | 493.4 | |||||||||
| 6 | 511.1 | 506.8 | 509.5 | 498.7 | 507.0 | 520.2 | 526.4 | 489.9 | |||||||||
| 7 | 483.9 | 510.2 | 516.2 | 501.6 | 504.4 | 506.9 | 509.1 | 508.6 | |||||||||
| 8 | 494.6 | 508.7 | 522.4 | 519.9 | 513.3 | 514.6 | 517.4 | 511.3 | |||||||||
| 9 | 510.0 | 508.3 | 498.0 | 519.6 | 504.0 | 512.2 | 504.9 | 504.2 | |||||||||
| 10 | 511.6 | 509.9 | 509.6 | 509.1 | 510.2 | 504.7 | 510.8 | 510.4 | |||||||||
| Average | 510.3 | 511.8 | 513.0 | 512.0 | 514.5 | 514.9 | 512.5 | 508.2 | |||||||||
| Grand Average | 512.2 | Standard Deviation | 11.25 | ||||||||||||||
| Grand Average | 512.2 | ||||||||||||||||
| Standard Deviation | 11.25 |
Result: Pass
The test was performed to determine the amount of material that can be removed when engaging the device. Looking at the upper and lower limit of delivery (for 30 seconds) vielded a difference of +23g and -8g versus the BMI suction valve. This equates to < 4.5% difference for the worst case view. It should be noted that doctors typically operate suction for only 5-10 seconds at a time. As a result this would further reduce any perceived variation to less than 3.3% difference (528.5/3010-512.2/3010=176.2-170.3= 5.9g; 5.9/176.3= 3.3%). The BMI unit additionally shows improved repeatability as compared to the predicate (SD of 11.25 versus 13.61) which will further reduce variability.
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4. Spring force and Displacement
| Olympus (predicate) | BMI 100305 | ||
|---|---|---|---|
| Force (lb) | Displacement (in) | Force (lb) | Displacement (in) |
| 2.02 | 0.190 | 2.98 | 0.193 |
| 2.04 | 0.191 | 2.51 | 0.198 |
| 2.16 | 0.188 | 2.86 | 0.200 |
| 2.07 | 0.187 | 2.92 | 0.194 |
| 2.05 | 0.181 | 2.97 | 0.200 |
| 2.21 | 0.186 | 3.02 | 0.199 |
| 1.95 | 0.183 | 2.94 | 0.194 |
| 2.15 | 0.197 | 2.90 | 0.196 |
| 2.56 | 0.194 | ||
| 2.96 | |||
| Average | Average | ||
| 2.0813 | 0.1876 | 2.862 | 0.1962 |
| Standard Deviation | Standard Deviation | ||
| 0.086 | 0.005 | 0.178 | 0.003 |
Result: Pass
The physics formula for the force of the spring is Hooke's Law F=- kx, where F is force, k is spring constant and x is displacement. The spring constants of the predicate and BMI suction valve were determined by using a force gage with a displacement gage. The measured values show a slight difference between the two devices, however, these differences cannot be perceived in blind tests by the tester or other selected parties (3 additional people). The BMI suction valve force and displacement is substantially equivalent to the predicate (MH-443).
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5. Sharp edges
| Olympus (predicate) | BMI 100305 |
|---|---|
| Pass | Pass |
| Pass | Pass |
| Pass | Pass |
| Pass | Pass |
| Pass | Pass |
| Pass | Pass |
| Pass | Pass |
| Pass | Pass |
| Pass | |
| Pass | |
| Average | Average |
| Pass | Pass |
Result: Pass
Testing showed that the BMI Suction valve does not pinch, cut, or tear the nitrile gloves. Test results confirm that BMI Suction Valve (100305) effectively attached and removed from corresponding port without posing a pinch, cut, or tear hazard to a healthcare professional's PPE (gloves). The BMI suction valve is substantially equivalent to the predicate (MH-443) for potential for tearing a glove.
Conclusion:
Based on these results, we have determined that the Byrne Medical DEFENDO™ Disposable Suction Valve is substantially equivalent to the Olympus MH-443 Suction Valve.
§ 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.