(18 days)
The Endius® FlexTip® Blade is an articulating soft tissue resector designed to be used as an accessory to an Arthroscopic Micro-discectomy (AMD) system or an equivalent and compatible drive system, to perform percutaneous lumbar discectomies.
The Endius FlexTip Blade is a disposable, articulating soft tissue resector designed to be used as an accessory to the Arthroscopic Micro-Discectomy (AMD) System or compatible drive systems. The FlexTip Blade has a flexible portion near the tip, allowing the tip to articulate under control of the lever in the handle. The inner shaft rotates inside the outer shaft providing cutting action through an aperture at the tip. Resected material is suctioned through the inner shaft and shaver handle into an inline external tissue trap. The Endius FlexTip Blade is sold sterile for single-use only.
This 510(k) submission for the Endius® FlexTip® Blade is for a medical device cleared in 2002. At that time, the requirements for demonstrating substantial equivalence were different from those for AI/ML-enabled devices today. This submission primarily focuses on comparing the new device to a predicate device based on design, materials, and intended use, rather than extensive performance studies with quantitative metrics on diagnostic accuracy.
Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert involvement, and ground truth establishment (which are standard for AI/ML device submissions) are not present or applicable in this document.
Here's an attempt to answer the questions based only on the provided text, highlighting where information is unavailable due to the nature of this type of medical device submission:
1. Table of acceptance criteria and the reported device performance
This document does not provide a table of acceptance criteria with specific performance metrics (e.g., sensitivity, specificity, accuracy) for the Endius® FlexTip® Blade. The clearance is based on demonstrating substantial equivalence to a predicate device rather than meeting pre-defined quantitative performance targets from a clinical study.
2. Sample size used for the test set and the data provenance
No test set, in the experimental sense for assessing AI/ML model performance, is mentioned in this document. The clearance is based on a comparison to a predicate device, focusing on design, materials, and intended use.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a mechanical surgical tool, not a diagnostic AI/ML system requiring expert-established ground truth for performance evaluation.
4. Adjudication method for the test set
Not applicable. There is no mention of a test set requiring adjudication in the context of this device.
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
Not applicable. This is a mechanical surgical tool, not an AI-assisted diagnostic device, so MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a mechanical surgical tool, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. For this type of medical device, "ground truth" in the context of AI/ML evaluation metrics is not relevant. The substantial equivalence is based on comparing the physical and functional characteristics to a legally marketed predicate device.
8. The sample size for the training set
Not applicable. There is no mention of a training set for an AI/ML model.
9. How the ground truth for the training set was established
Not applicable. There is no mention of a training set or ground truth in the context of an AI/ML model.
Summary of the Study (or lack thereof, in the AI/ML context):
The provided document describes a 510(k) Premarket Notification for the Endius® FlexTip® Blade. The "study" described, relevant to a medical device from 2002, is a demonstration of substantial equivalence to a predicate device, the Endius Endo-Bend Shaver System (K950054).
The acceptance criteria for this submission are implicit in the FDA's "substantial equivalence" determination. This means the new device (Endius® FlexTip® Blade) must be shown to be as safe and effective as a legally marketed predicate device. This is typically achieved by demonstrating:
- Same intended use: The document states both devices are "articulating soft tissue resector(s) designed to be used as an accessory to an Arthroscopic Micro-discectomy (AMD) system or an equivalent and compatible drive system, to perform percutaneous lumbar discectomies."
- Same technological characteristics, or different technological characteristics that do not raise new questions of safety and effectiveness: The new device is described as having a "flexible portion near the tip, allowing the tip to articulate under control of the lever in the handle," which is an evolution from the predicate. The submission would have focused on justifying that this design change does not introduce new risks or reduce effectiveness, likely through engineering analysis, material testing, and potentially bench testing of the cutting action or articulation mechanism.
The document does not detail specific performance studies with quantitative outcomes (like accuracy, sensitivity, etc.) on human subjects or datasets, as would be required for AI/ML devices. Instead, it relies on the comparison to a previously cleared device. The "proof" that the device meets "acceptance criteria" is the FDA's letter stating that the device is "substantially equivalent" to the predicate.
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Endius, Inc. Endius® FlexTip™ Blade
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AUG 2 3 2002
Section 7 - 510(k) Summary
| 7.1Statement | Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Endius, Inc. isrequired to submit with this Premarket Notification either an "... adequatesummary of any information respecting safety and effectiveness or state thatsuch information will be made available upon request of any person." Endius,Inc. chooses to submit a summary of information respecting safety andeffectiveness. According to §513(i)(3)(B), "Any summary under subparagraph(A) respecting a device shall contain detailed information regarding dataconcerning adverse health effects..."The summary regarding the adverse health effects of the modified device,Endius® FlexTip® Blade is provided below. |
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| 7.2Submitter | Endius, Inc.23 West Bacon StreetPlainville, MA. 02762 |
| 7.3CompanyContact | Christine Kuntz-NassifDirector, Regulatory Affairs508-643-0983 Ext. 114 |
| 7.4DeviceName | Proprietary Name:Endius® FlexTip® BladeCommon Name:Arthroscopic Accessory: Bendable ShaverClassification Name:Arthroscope (HRX) |
| 7.5PredicateDevice | Endius Endo-Bend Shaver System: K950054 |
| 7.6DeviceDescription | The Endius FlexTip Blade is a disposable, articulating soft tissue resectordesigned to be used as an accessory to the Arthroscopic Micro-Discectomy(AMD) System or compatible drive systems. The FlexTip Blade has a flexibleportion near the tip, allowing the tip to articulate under control of the lever inthe handle. The inner shaft rotates inside the outer shaft providing cuttingaction through an aperture at the tip. Resected material is suctioned through theinner shaft and shaver handle into an inline external tissue trap. The EndiusFlexTip Blade is sold sterile for single-use only. |
| 7.7DeviceIndicationsFor Use | The Endius® FlexTip® Bladeis an articulating soft tissue resector designed to beused as an accessory to an Arthroscopic Micro-discectomy (AMD) system or anequivalent and compatible drive system, to perform percutaneous lumbardiscectomies. |
| 7.8SubstantialEquivalence | The proposed Endius FlexTip BladeSystem is substantially equivalent to theEndius Endo-Bend System, K950054. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized, curved lines that resemble a person. The logo is simple and recognizable.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 3 2002
Endius, Inc. Christine Kuntz-Nassif Director, Regulatory Affairs 23 West Bacon Street Plainville, Massachusetts 02762
Re: K022578
Trade/Device Name: Endius® Flextip® Blade Regulation Number: 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: August 2, 2002 Received: August 5, 2002
Dear Ms. Kuntz-Nassif:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
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Page 2 - Ms. Christine Kuntz-Nassif
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N Milken
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: Endius® FlexTip® Blade
Indications for Use:
The Endius® FlexTip® Blade is an articulating soft tissue resector designed to be used as an accessory to an Arthroscopic Micro-discectomy (AMD) system or an equivalent and compatible drive system, to perform percutaneous lumbar discectomies.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurence of CDRH, Office of Device Evaluation (ODE)
(Posted July 1, 1998)
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(Optional Format 3-10-98)
Mark A. Milliman
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number -
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.