(34 days)
The Endius Suction /Irrigation Device is intended to be used to irrigate/aspirate fluids during Endoscopic and open spinal surgical procedures.
The Endius Endoscopic Irrigation/ Suction Device is intended to be used to irrigate and aspirate fluids during Endoscopic and open spinal Procedures and therefore to assist in the visualization. The device consists of a single -use disposable tubing set/trumpet valve which is intended to be attached to a re-usable suction/irrigation attachment.
The provided documents do not contain information regarding the acceptance criteria, specific studies, or detailed performance data for the Endius Suction/Irrigation Device that would allow for a comprehensive answer to all parts of your request.
The documents are primarily an FDA 510(k) clearance letter and a 510(k) summary, which focus on demonstrating substantial equivalence to a predicate device rather than presenting detailed study results against specific acceptance criteria.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document does not list specific acceptance criteria for performance, nor does it report detailed performance metrics. The 510(k) summary provides a comparison table of the Endius device with the predicate device (EndoSI™ Suction/Irrigation Device) based on features like intended use, materials, sterilization, product labeling, and packaging. This table highlights similarities and minor differences, but it doesn't quantify performance against acceptance criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The documents do not describe any specific testing with a 'test set' in the context of clinical or performance studies with sample sizes. The 510(k) process primarily relies on demonstrating substantial equivalence, often through design and functional comparisons, and sometimes non-clinical (e.g., bench) testing, rather than large-scale clinical trials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Cannot be provided. The documents do not mention any studies involving experts establishing ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. No information on adjudication methods for a test set is present.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Cannot be provided. The device is a "Suction/Irrigation Device" used in surgical procedures, not an AI-powered diagnostic or imaging interpretation tool. Therefore, MRMC studies involving human readers and AI assistance are not applicable and are not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. This device is a physical instrument for suction and irrigation during surgery, not an algorithm. Standalone algorithm performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Cannot be provided. Since no specific performance studies or clinical trials are detailed, there is no mention of ground truth establishment. The substantial equivalence largely relies on comparing design, materials, and intended use with the predicate device, assuming the predicate's effectiveness and safety are established.
8. The sample size for the training set
- Cannot be provided. This device is a physical medical instrument, not an AI model that requires a training set.
9. How the ground truth for the training set was established
- Cannot be provided. As above, a training set and its ground truth are not applicable to this type of device.
Summary of what the documents do provide:
- Device Name: Endius Suction/Irrigation Device
- Intended Use: To irrigate and aspirate fluid during Endoscopic and open spinal procedures.
- Predicate Device: EndoSI™ Suction/Irrigation Trumpet Valve and Accessories
- Comparison: The 510(k) summary provides a table comparing the Endius device to the predicate based on intended use (expanded to spinal procedures for Endius), materials (PVC, ABS, Delrin for Endius vs. PVC, ABS for predicate), sterilization (gamma irradiation for both), product labeling (sterility and re-usability difference for the attachment part), and packaging.
- Substantial Equivalence: The FDA determined the Endius device is substantially equivalent to the predicate device. This determination is based on the comparison provided in the 510(k) submission, suggesting that the differences do not raise new questions of safety or effectiveness.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Endius, Inc. Ms. Susan Finneran Manager, Quality Assurance and Regulatory Affairs 23 West Bacon Street Plainville, MA 02762
JUL 2 7 2015
Re: K992535 Trade/Device Name: Endius Suction/Irrigation Device Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCX Dated (Date on orig SE ltr): July 28, 1999 Received (Date on orig SE ltr): July 29, 1999
Dear Ms. Finneran,
This letter corrects our substantially equivalent letter of September 1, 1999.
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
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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-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,
Benjamin R. Fisher -S
Beniamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K992535
510(k) Number (if known):
Device Name: Endius Suction /Irrigation Device
Indications for Use: The Endius Suction Device is intended to be used to irrigate and aspirate fluid during Endoscopic and open spinal procedures
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurence of CDRH, Office of Device Evaulation (ODE)
(Optional Format 3-10-98)
(Posted July 1, 1998)
ー
Prescription Use
(Per 21 CFR 801.109)
Bcotter
Restorative Devices
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Section 6 - 510(k) Summary of Safety and Effectiveness
| 6.1Statement | This summary of 510(k) safety and effectiveness information is being submittedin accordance with the requirements of SMDA 1990 and CFR 807.92 | ||
|---|---|---|---|
| 6.2Submitter | Endius, Inc.23 West Bacon StreetPlainville, MA. 02762 | ||
| 6.3CompanyContact | Susan FinneranQA/ RA Manager508-643-0983 | ||
| 6.4Device Name | Proprietary Name: Endius Suction/Irrigation InstrumentCommon Name: Endoscopic Suction/ Irrigation DeviceClassification Name: Endoscope and Accessories | ||
| 6.5PredicateLegallyMarketedDevices | EndoSITM Suction/Irrigation Trumpet Valve and Accessories | ||
| 6.6DeviceDescription | The Endius Endoscopic Irrigation/ Suction Device is intended to be used toirrigate and aspirate fluids during Endoscopic and open spinal Procedures andtherefore to assist in the visualization. The device consists of a single -usedisposable tubing set/trumpet valve which is intended to be attached to a re-usable suction/irrigation attachment. |
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| 6.7DeviceIndications andIntended use | The Endius Suction /Irrigation Device is intended to be used toirrigate/aspirate fluids during Endoscopic and open spinal surgical procedures. |
|---|---|
| -------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------- |
| 6.8SubstantialEquivalence | The Endius Endoscopic Spinal Access System is substantially equivalent to theEndoSI™ Suction/Irrigation Trumpet Valve and Accessories |
|---|---|
| ----------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------- |
| Device Name | EndoSIT™Suction/Irrigation Device | Endius Suction/Irrigation Device |
|---|---|---|
| Intended use | Irrigation and Aspirationof fluid duringlaparoscopic procedures | Irrigation and Aspiration of fluidduring Endoscopic Spinalprocedures. |
| Materials | PVC, ABS | PVC, ABS, Delrin |
| Sterilization Methods | Sterile componentssterilized by gammairradiation | Sterile components sterilized bygamma irradiation |
| ProductLabeling | Trumpet Valve: Sterile,single useSuction/Irrigationattachment: Sterile,singleuse | Trumpet Valve: Sterile, single useSuction/Irrigation attachment:Non-Sterile, re-usable |
| Packaging | Sterile componentspackaged in Tyvek pouch | Sterile components packaged inTyvek pouch |
Applicant Susan Din
Date 7/27/99
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§ 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.