(39 days)
The EndoArm system consists of the EndoArm, a stabilizing fixation(adapter), Neuroendoscope (A1**A series). A number of components and accessories are also necessary for this system.
● EndoArm
This product has been designed for manipulation and positioning of the Neuroendoscope during neurosurgery and spinesurgery.
● Neuroendoscopes (A81000A, A81001A, A81002A, A81010A, A81011A, A81012A, A81031A, A81032A, A81041A, A81042A)
The Neuroendoscopes are intended for use in observation and diagnosis of the brain ventricles and brain parenchyma, such as observation and diagnosis of cerebral aneurysms, hypophysis tumors, hematomas, brain tumors, cerebral vascular systems, cranial nerve and vascular compression syndromes as well as observation and diagnosis of lumber and cervical spine, such as herniated disc material, nerve roots and nucleus material.
Subject device is a neurological endoscopy system, which consists of EndoArm, a stabilizing fixation component (adapter) and a family of rigid neurological endoscope. A number of component and accessories are also necessary for this system.
(1) EndoArm:
Mechanical: The Endoarm counter balance arm is designed to deliver smooth endoscope movement and steady fixation by use of compressed nitrogen gas to control the arm movement. The shape of the stand differs from the predicate device in that the predicate device is a bedside fixed design and subject device is a floor stand type. This allows physicians to move the endoscope near the target site only.
Illumination: The illumination is supplied by the Neuroendoscope through the light guide cable connected to the separate high intensity light source, OLYMPUS CLV-S40. This light source utilizes a Xenon 300W bulb.
Imaging: Another significant difference from the predicate device is the ability of the EndoArm to manage image data from the Neuroendoscope and allow the user to adjust zoom, focus and manage intego adda resiste the EndoArm from fine adjustment of the endoscope potion to image adjustment by one hand. This feature is accomplished by the connection of the Neuroendoscope through the adapter (A81020A) on the EndoArm. The image from the distal end of Neuroendoscope is transmitted to the monitor via the CCD of OTV-S7V camera head, mounted in the EndoArm.
(2) Neuroendoscope ( model: A81000A, A81001A, A81002A,A81010A, A81011A, A81012A, A81031A, A81032A, A81041A, A81042A): Ten telescope models are discussed in this premarket notification. The range of specifications covers two different insertion diameters ( ø 2.7mm / ø 4mm), five different working lengths (107mm/ 110mm / 112mm/134mm/ 137mm) and five different fields of view (0/ 30/ 70/ -30/-70 ( rorme). The crank shaped endoscope offers the largest operation space and microscopic dog. The craint on onail. In one doscope models are substantially equivalent to the predicate Neuroendoscope (#K971340).
(3) Adapter ( model: A81020A): The subject device is an adapter for connecting the Neuroendoscope A810**A series to the EndoArm stabilizing fixation device.
This submission is a 510(k) premarket notification for the OLYMPUS EndoArm, a neurological endoscopy system. The provided document does not contain specific acceptance criteria or a study proving the device meets acceptance criteria in the manner typically associated with clinical performance studies for AI/ML devices.
The submission is a declaration of substantial equivalence to previously marketed predicate devices (K971340, K982133, K991989). For such devices, acceptance criteria are primarily related to safety, operational specifications, and performance being equivalent to the predicate devices, rather than a clinical performance study with specific metrics like sensitivity or specificity.
Here's an analysis based on the information provided, highlighting why certain questions cannot be answered:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied from 510(k) "Substantial Equivalence") | Reported Device Performance (from "Comparison Technological Characteristics") |
|---|---|
| EndoArm (Manipulation and Positioning) | |
| Materials contacting patient: None | None |
| Support system: Floor stand | Floor stand (different from predicate's bedside fixed design) |
| Driving power: Compressed Nitrogen gas | Compressed Nitrogen gas |
| Attachment of TV camera: Attached to the Grip of the Arm | Attached to the Grip of the Arm (different from predicate's direct attachment to endoscope) |
| Zooming capability: Equipped | 2 times (predicate: Not equipped) |
| Image rotation capability: Equipped | 360 degrees (predicate: Not equipped) |
| Design compliance with safety standards | Meets IEC60601-1, IEC60601-1-1, IEC60601-2-18 |
| Neuroendoscopes (Observation and Diagnosis) | |
| Range of Directions of View | 0°, 30°, 70°, -30°, -70° (similar to predicate's 0°, 30°, 70° but expanded) |
| Range of Working Lengths | 107mm, 110mm, 112mm, 134mm, 137mm (different from predicate's 155mm, 158mm) |
| Range of Outer Diameters | 2.7mm, 4mm (similar to predicate's 4mm but expanded) |
| Biocompatibility of patient-contacting materials | Identical materials to cleared 510(k)s, confirmed with ISO 10993-1 |
Study Proving Acceptance Criteria:
The document explicitly states: "Therefore the clinical data is not necessary for its evaluation of safety or effectiveness of the subject device." This indicates that a formal clinical study to prove acceptance criteria in the context of diagnostic or treatment efficacy was not performed or required for this 510(k) submission. Instead, the "study" is a technical comparison and demonstration of substantial equivalence to existing legally marketed devices, primarily focusing on design, materials, and functional specifications, along with compliance to relevant safety standards.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. No clinical test set or data for performance evaluation (e.g., diagnostic accuracy) was used. The submission relies on technical specifications and comparison to predicates.
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)
- Not applicable / Not provided. No ground truth establishment related to clinical diagnostic accuracy was performed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. No test set requiring expert adjudication was used.
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 / Not provided. This device is a neuroendoscopy system, not an AI/ML diagnostic or assistive device. No MRMC study was mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable / Not provided. This is a medical device (endoscopy system), not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not provided for clinical performance. The "ground truth" for this submission revolves around established engineering and material standards (e.g., IEC standards, ISO 10993-1) and the functional specifications of the predicate devices.
8. The sample size for the training set
- Not applicable / Not provided. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable / Not provided. This is not an AI/ML device that requires a training set.
Summary of the "Study" for this 510(k) Submission:
The "study" presented in this 510(k) summary is a technical comparison against predicate devices and adherence to recognized safety standards. The manufacturer asserts that the OLYMPUS EndoArm is substantially equivalent to the identified predicate devices by demonstrating:
- Similar Intended Use: The intended uses for manipulation and positioning of neuroendoscopes and for observation/diagnosis are clearly stated and aligned with the general use of neurological endoscopes.
- Technological Characteristics Comparison: Detailed tables compare the EndoArm and Neuroendoscopes to their respective predicates, highlighting similarities and differences in features like support systems, driving power, imaging capabilities (zoom, rotation), directions of view, working lengths, and outer diameters. Differences are argued not to affect safety or effectiveness.
- Materials Equivalence and Biocompatibility: Patient-contacting materials are stated to be identical to previously cleared devices and confirmed with ISO 10993-1.
- Safety Standards Compliance: The device meets international safety standards (IEC60601-1, IEC60601-1-1, IEC60601-2-18).
The conclusion explicitly states that "When compared to the predicate devices, EndoArm does not incorporate any significant changes in the intended use, method of operation, material, or design that could affect the safety or effectiveness. Therefore the clinical data is not necessary for its evaluation of safety or effectiveness of the subject device." This confirms that the substantiation for this 510(k) relies on comparison to predicates and adherence to standards, not on new clinical performance data.
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September 2. 2004
SMDA 510(k) SUMMARY
OLYMPUS EndoArm
This summary of 510(k) safety and effectiveness information is being submitted in accordance with This Gammary of OTO(1) Salesy and 21CFR, Part 807, Subpart E, Section 807.92.
A. General Information
| 1. Applicant:& Manufacture | OLYMPUS Corporation5128 Ooaza Ina, Ina-shi, Nagano, Japan, 396-0021(Registration Number : 9614612 ) |
|---|---|
| 2. Submission Correspondent: | Masao WadaOLYMPUS Corporation2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan, 192-8507Telephone : 81-426-42-2891Facsimile : 81-426-42-2291E-mail : m_wada@ot.olympus.co.jp(Registration Number : 8010047 ) |
| 3. Initial Importer : | OLYMPUS AMERICA INC.Two Corporate Center Drive, Melville, NY 11747-9058(Registration Number : 2429304 ) |
| 4. Official Correspondent: | Laura Storms-TylerDirector Regulatory Affairs and Quality AssuranceOLYMPUS AMERICA INC.Two Corporate Center Drive, Melville, NY 11747-9058Telephone : 631-844-5688Facsimile : 631-844-5554E-mail : Laura Storms-Tyler@olympus.com(Registration Number : 2429304 ) |
B. Device Identification
-
- Common/Usual Name : Neuroendoscope
- OLYMPUS EndoArm 2. Device Name :
3. Classification Name :
| CFR Number | Classification Name | Class | Product Code |
|---|---|---|---|
| 882.1480 | Neurological endoscope | II | 84 GWG |
C. Identification of the predicate or legally marketed device(s)
The following listed devices are the predicate medical devices;
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| Model | 510(k)# | Manufacturer | Class | ProductCode |
|---|---|---|---|---|
| A7594A, A7595A, A7597ANeuroendoscope | #K971340 | OLYMPUS Co., | II | GWG |
| Endoscopic system forLumber hernia discectomy | #K982133 | OLYMPUS Co., | II | HRX |
| Point SetterHolder for rigid endoscopeand flexible endoscope | #K991989 | Mitaka Kohki Co., Ltd | II | GWG |
D. Device Description
1. Summary
Subject device is a neurological endoscopy system, which consists of EndoArm, a stabilizing fixation component (adapter) and a family of rigid neurological endoscope. A number of component and accessories are also necessary for this system.
(1) EndoArm:
Mechanical
The Endoarm counter balance arm is designed to deliver smooth endoscope movement and steady fixation by use of compressed nitrogen gas to control the arm movement. The shape of the stand differs from the predicate device in that the predicate device is a bedside fixed design and subject device is a floor stand type. This allows physicians to move the endoscope near the target site only.
Illumination
The illumination is supplied by the Neuroendoscope through the light guide cable connected to the separate high intensity light source, OLYMPUS CLV-S40. This light source utilizes a Xenon 300W bulb.
Imaging
Another significant difference from the predicate device is the ability of the EndoArm to manage image data from the Neuroendoscope and allow the user to adjust zoom, focus and manage intego adda resiste the EndoArm from fine adjustment of the endoscope potion to image adjustment by one hand.
This feature is accomplished by the connection of the Neuroendoscope through the adapter (A81020A) on the EndoArm. The image from the distal end of Neuroendoscope is transmitted to the monitor via the CCD of OTV-S7V camera head, mounted in the EndoArm.
(2) Neuroendoscope ( model: A81000A, A81001A, A81002A,A81010A, A81011A, A81012A, A81031A, A81032A, A81041A, A81042A)
Ten telescope models are discussed in this premarket notification. The range of specifications covers two different insertion diameters ( ø 2.7mm / ø 4mm), five different working lengths (107mm/ 110mm / 112mm/134mm/ 137mm) and five different fields of view (0/ 30/ 70/ -30/-70 ( rorme). The crank shaped endoscope offers the largest operation space and microscopic dog. The craint on onail. In one doscope models are substantially equivalent to the predicate Neuroendoscope (#K971340).
(3) Adapter ( model: A81020A)
of The subject device is an adapter for connecting the Neuroendoscope A810**A series to
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the EndoArm stabilizing fixation device.
2. Design
EndoArm has been designed, manufactured and tested in compliance with voluntary safety standards. It meets the requirement of IEC60601-1, IEC60601-1-1and IEC60601-2-18.
3. Materials
All the patient contacting materials used in this Telescope and ancillary equipment are identical materials that had cleared the past 510(k) submissions. And all materials have been confirmed with ISO 10993-1.
4. Intended Use of the device
The EndoArm system consists of the EndoArm, a stabilizing fixation(adapter), Neuroendoscope(A1**A series). A number of components and accessories are also necessary for this system.
(1) EndoArm
This product has been designed for manipulation and positioning of the Neuroendoscope during neurosurgery and spinesurgery.
- (2) Neuroendoscopes (A81000A, A81001A, A81002A, A81010A, A81011A, A81012A, A81031A, A81032A, A81041A, A81042A)
The Neuroendoscopes are intended for use in observation and diagnosis of the brain ventricles and brain parenchyma, such as observation and diagnosis of cerebral aneurysms, hypophysis tumors, hematomas, brain tumors, cerebral vascular systems, cranial nerve and vascular compression syndromes as well as observation and diagnosis of lumber and cervical spine, such as herniated disc material, nerve roots and nucleus material
5. Comparison Technological Characteristics
(1) EndoArm
| Items | EndoArm(Predicate Device) | Point Setter K991989(Predicate Device) | Lumber hernia discectomy K982133(Predicate Device) |
|---|---|---|---|
| Manufacture | OLYMPUS | Mitaka Kohki Co., Ltd | OLYMPUS |
| Materials contactsto patient | None | None | None |
| Support system | Floor stand | Mounted on bed side | Mounted on bed side |
| Driving power | CompressedNitrogen gas | Compressed Nitrogengas | Manual |
| Attachment of TVcamera | Attached to theGrip of the Arm | Attached to Endoscope directly | Attached to Endoscope directly |
| Zooming | 2 times | Not equipped | Not equipped |
| Image rotation | 360 degrees | Not equipped | Not equipped |
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(2) Neuroendoscopes (Telescopes)
| Item | Subject Device(A810***A series) | Predicate Device(A7594A,A7595A,A7597A) |
|---|---|---|
| Direction ofView | 0° : A81000A, A81010A30° : A81001A, A81011A70° : A81002A, A81012 A-30° : A81031A, A81041A-70° : A81032A, A81042A | 0° : A7594A30° : A7595A70° : A7597A |
| Working Length | 112mm : A81000A110mm : A81001A, A81031A107mm : A81002A, A81032A137mm : A81010A ,A81011A, A81012 A,134mm : A81041A, A81042A | 158mm : A7594A, A7595A155mm : A7597A |
| Outer Diameter | 4mm : A81000A, A81001A, A81002A,A81031A, A81032A2.7mm : A81010A, A81011A, A81012A,A81041A, A81042A | 4mm: A7594A, A7595A,A7597A |
6. Conclusion
When compared to the predicate devices, EndoArm does not incorporate any significant changes in the intended use, method of operation, material, or design that could affect the safety or effectiveness.
Therefore the clinical data is not necessary for its evaluation of safety or effectiveness of the subject device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird in flight, composed of three curved lines. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 1 2004
Olympus Corporation c/o Mr. Neil E. Devine Entela, Inc. 3033 Madison Avenue SE Grand Rapids, Michigan 49548
Re: K043128
Trade/Device Name: Olympus EndoArm Regulation Number: 21 CFR 882.1480 Regulation Name: Neurological endoscope Regulatory Class: II Product Code: GWG Dated: December 14, 2004 Received: December 16, 2004
Dear Mr. Devine:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(x) prematice is substantially equivalent (for the indications
referenced above and have determined the device is substantially interests to felerenced above and nave uctoringed in acketed predicate devices marketed in interstate for use stated in the enclosure) to regarly marketed produced Device Amendments, or to commerce prior to May 26, 1970, the charactiven asso of the Federal Food. Drug, devices that have been recure approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA and Cosment Act (Act) that do not require approval controls provisions of the Act. The Act. The You may, merelore, market the devices, basjos, bases were mements for annual registration, listing of
eneral controls provisions of the Act include requirements for annual re general controls provisions of the frectiners and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it (PMA), it If your device is classified (see above) mis existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation FDA may be subject to such additional controller "Entrologiations" on the 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In a be found in the Ood of I outstal concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualice of a substantial other requirements of the Act
that FDA has made a determination that your device complies with other requirements of t that FDA has made a delemination that Jour as 100 received agencies. You must of any Pederal Statutes and regulations adminitered or registration and listing (21 l
comply with all the Act's requirements, including, but not limited to: ret comply with all the Act Stequirements, mercessed ing practice requirements as set CFR Parl 807); labelling (21 CFR Part 820); good if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, 1050 form in the quality systems (QD) regalantin (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1
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Page 2 - Mr. Neil E. Devine
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin maneting your antial equivalence of your device to a legally premits in the around . The PDA midning of backander 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), please If you desire specific advice for your ac not the career note the regulation entitled, Colliact the Office of Comphaller and (21 the Part 807.97). You may obtain Missuranting by relevelse to premainters in the Act from the Division of Small other general information on your roppoints. 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,
Miriam C. Provost
for Gail McWhirter, Ph.D., M.D.
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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Indications for Use
510(k) Number (if known):
Device Name: OLYMPUS EndoArm
Indications For Use:
The EndoArm system consists of the EndoArm, a stabilizing fixation(adapter), Neuroendoscope The EndoAthl System consists of the Enoon int, a stablians mater (casples), in this system.
● EndoArm
EndoArm
This product has been designed for manipulation and positioning of the Neuroendoscope during Neurosurgery and spinesurgery.
● Neuroendoscopes (A81000A, A81001A, A81002A, A81010A, A81011A, A81012A, A81031A, A81032A. A81041A, A81042A)
The Neuroendoscopes are intended for use in observation and diagansis of the brain ventine hypophytonic I he Neuroenchyma, such as observation and diagnosis of cerebral aneurysms, hypophysis and brain patenchyma, such as observation and diegries, cranial nerve and vascular tumors, nematornas, brain tumors, cercorary of observation and diagnosis of the lumber compression syndrones as won as monounter in the move roots and nucleus material.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR x
Over - The - Counter-Use (Part 21 CFR 801 Subpart C)
(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IS NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
K043128 510(k) Number.
7
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§ 882.1480 Neurological endoscope.
(a)
Identification. A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.(b)
Classification. Class II (performance standards).