(61 days)
Not Found
No
The device description and performance studies focus on mechanical and functional aspects of a disposable suction valve, with no mention of AI/ML technologies or data processing beyond basic measurements.
No.
The device controls the suction function on an endoscope and is intended for use during a GI endoscopic procedure to remove fluid. It does not directly treat or mitigate a disease or condition.
No
The Intended Use and Device Description clearly state that the DEFENDO™ Disposable Suction Valve is used to control the suction function on an endoscope to remove fluid during GI endoscopic procedures. It does not analyze, measure, or process any data to provide diagnostic information.
No
The device description clearly states it is a "disposable device that attaches to the suction cylinder of an endoscope" and describes its physical mechanism of action (depressing the valve). This indicates a physical hardware component, not a software-only device.
Based on the provided information, the DEFENDO™ Disposable Suction Valve is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to control suction during a GI endoscopic procedure. This is a functional device used during a medical procedure on a patient, not a device used to examine specimens in vitro (outside the body) to diagnose a condition.
- Device Description: The description details a mechanical valve that attaches to an endoscope to control suction. This aligns with a surgical/procedural accessory, not a diagnostic test.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples, detect markers, or provide diagnostic information. Its sole purpose is to facilitate the removal of fluids during the procedure.
IVD devices are specifically designed to perform tests on specimens (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The DEFENDO™ Disposable Suction Valve does not fit this description.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
ODC, FDF
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)
Bench testing was performed to confirm that the disposable BMP-215 DEFENDO™ Disposable Suction Valve is equivalent to the predicate Olympus® MH-443 Suction Valve.
Studies conducted:
- Connection to the endoscope: Tested the ease of connection and alignment with port notches for both the subject device and predicate. Sample size not explicitly stated, but results show "Smooth" for 10 trials for both devices. Result: Pass, found to be similar and substantially equivalent.
- Priming time: Measured the time for water to travel from the reservoir to the distal tip of the endoscope. Sample size was 8 trials for the predicate and 10 trials for the subject device. Result: Pass, no significant difference found, average priming time for predicate was 4.16 and for BMI was 3.92.
- Material quantity removed: Tested the suction ability by placing an endoscope into a filled water basin and depressing the suction valve for thirty seconds, ten times each for eight valves of both the subject device and predicate. Result: Pass, differences were nominal (+23g and -8g or
§ 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
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
2
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
3
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510(k) Summary of Safety and Effectiveness Data
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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 EXERA | ||
| Colonovideoscopes | 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 Advisory | |||
| Committee | Gastroenterology/Urology | Gastroenterology/Urology | Yes |
| 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. | The Olympus® Suction valve | ||
| is intended to be used to | |||
| control the Suction function | |||
| on an Olympus ®endoscope | |||
| during a GI endoscopic | |||
| procedure. | Yes | ||
| Sterile | Yes | No, user must sterilize | No |
| Single Use | Yes | No, re-sterilize, re-use | No |
| Compatible | |||
| Endoscope(s) | Olympus® | ||
| 140/160/180/240/260 series | |||
| endoscopes | Olympus® | ||
| 140/160/180/240/260 series | |||
| endoscopes | Yes | ||
| Patient Population | Male/Female, Pediatric to | ||
| Adult | Male/Female Pediatric to | ||
| Adult | Yes | ||
| Reusable or | |||
| disposable | 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)
5
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 to | |
| the endoscope | The valve must connect to the endoscope by aligning valve with port |
| and pressing down. Must not be cumbersome to attach. | |
| 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). | |
| 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. | |
| Spring Force & | |
| Displacement | The device must be comparable to the predicate device in terms of |
| force required to activate the button. | |
| 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. |
Sq.
6
| 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.
7
-
- 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.
ન
8
. ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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
9
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 |
| Standard | |
| Deviation | Standard |
| Deviation | |
| 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
10
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 | |
| Material | |||||||||
| Removed | |||||||||
| In 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
11
Traditional 510(k) Submission
| Byrne Medical Suction Valve | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sample | |||||||||||||||||
| Test | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | |||||||||
| Material | |||||||||||||||||
| Removed | |||||||||||||||||
| in 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