(24 days)
Not Found
No
The description focuses on the optical and mechanical aspects of the arthroscope and its performance in visualization and illumination. There is no mention of AI, ML, image processing for analysis, or any data processing beyond basic image capture.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device provides an internal view for "examination, diagnosis, and/or therapy." While it primarily focuses on visualization, the inclusion of "therapy" qualifies it as a therapeutic device.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device is "introduced into a patient to provide an internal view or image of the interior of a joint for examination, diagnosis, and/or therapy." The mention of "diagnosis" clearly indicates its use as a diagnostic device.
No
The device description explicitly details a physical optical instrument with a working length, diameter, field of view, direction, and battery power. It also mentions physical testing like leak tests, distal tip smoothness, and cannula interface tests, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. They are used outside of the body.
- Device Function: The description clearly states that the Nuvis® Battery Arthroscope is an endoscopic device introduced into a patient to provide an internal view or image. It is used inside the body for direct visualization.
The device is an in vivo diagnostic and therapeutic tool, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
Integrated Endoscopy's Nuvis® Battery Arthroscope is an endoscopic device introduced into a patient to provide an internal view or image of the interior of a joint for examination, diagnosis, and/or therapy . Integrated Endoscopy's Nuvis® Battery Arthroscopes are indicated for use in arthroscopic procedures performed in the knee, shoulder, hip, wrist (carpel tunnel syndrome), temporal mandibular joint, ankle, elbow, and feet (plantar fascia release).
Product codes (comma separated list FDA assigned to the subject device)
HRX
Device Description
Integrated Endoscopy's Battery Arthroscope is an optical instrument designed for illumination and visualization of internal anatomy of a patient within the knee, shoulder, and hip joint. Integrated Endoscopy's Battery Arthroscope has a 141mm working length, an outside diameter of 4mm, a field of view of 105 °, and a direction of 30 °. The Arthroscope is Battery Powered and three selectable light settings. The Arthroscope is designed to be used with a cannula compatible with a 4mm x 30° arthroscope with a working length of 141mm. The Arthroscope is supplied sterile and is for SINGLE USE ONLY. DO NOT REUSE OR RE-STERILIZE.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical instrument providing internal view or image of the interior of a joint.
Anatomical Site
knee, shoulder, hip, wrist (carpel tunnel syndrome), temporal mandibular joint, ankle, elbow, and feet (plantar fascia release)
Indicated Patient Age Range
Not Found
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)
The Nuvis® Battery Arthroscope was subjected to and passed electromagnetic compatibility (EMC), electrical safety and biocompatibility testing requirements. The Nuvis® Battery arthroscope met all specified design and performance requirements. The performance testing included comparison of images taken by the Integrated Endoscopy Nuvis® Battery Arthroscope and its predicate, the Integrated Endoscopy NuVis® Arthroscope.
Testing was performed on post-sterile devices to ensure device functionality and suitability for its intended use. The test regimen consisted of the following: visual inspection, leak and condensation test, visual image check, pointer/direction test, distal tip smoothness, scope diameter/cannula interface test, angle of view (AOV) measurement, field of view (FOV) measurement, resolution test, and LED light intensity verification, and PX3 Liquid Penetration and Ingress tests, biocompatibility testing, packaging testing (pouch seal and transportation valuation testing, and shelf life stability testing.
All requirements were met for the Nuvis® Battery Arthroscope. Performance bench testing demonstrated the Nuvis® Battery Arthroscope can perform as intended.
Animal studies were not performed nor required.
Clinical studies were not performed nor required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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July 11, 2019
Integrated Endoscopy, Inc. Dr. Albert Rego VP Regulatory & Quality 16 Technology Drive. Suite 165 Irvine, California 92618
Re: K191594
Trade/Device Name: Nuvis Battery Arthroscope Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: June 15, 2019 Received: June 17, 2019
Dear Dr. Rego:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 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.
1
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 adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191594
Device Name Nuvis® Battery Arthroscope
Indications for Use (Describe)
Integrated Endoscopy's Nuvis® Battery Arthroscope is an endoscopic device introduced into a patient to provide an internal view or image of the interior of a joint for examination, diagnosis, and/or therapy . Integrated Endoscopy's Nuvis® Battery Arthroscopes are indicated for use in arthroscopic procedures performed in the knee, shoulder, hip, wrist (carpel tunnel syndrome), temporal mandibular joint, ankle, elbow, and feet (plantar fascia release).
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Image /page/3/Picture/0 description: The image contains the logo for Integrated Endoscopy. The logo features the word "integrated" in a lowercase, sans-serif font, stacked above the word "endoscopy" which is also in a lowercase, sans-serif font. To the right of the text is a triangular shape with a gradient of purple and blue. The logo is clean and modern, suggesting a focus on technology and innovation in the field of endoscopy.
- l. SUBMITTER: Integrated Endoscopy 16 Technology Dr. Ste. 165 Irvine, CA
| Contact Person: | Albert Rego, Ph.D.
Vice President Regulatory & Quality |
|-----------------|-----------------------------------------------------------|
| Phone: | 949.632.8126
Email: albert@iescope.com |
| Date Prepared: | July 5, 2019 |
|---|---|
| ---------------- | -------------- |
- ll. DEVICE:
III.
| Trade Name | Nuvis® Battery Arthroscope |
|---|---|
| Common/Classification Name: | Arthroscope, Class II |
| Regulation Number/Name: | 21 CFR §888.1100, Arthroscope (Performance Standards) |
| Review Panel: Product Code: | Orthopedic/HRX, Arthroscope |
| PREDICATE DEVICE: |
510(k) Number:K140903 Product Name: Nuvis® Arthroscope Manufacturer: Integrated Endoscopy
IV. DEVICE DESCRIPTION:
Integrated Endoscopy's Battery Arthroscope is an optical instrument designed for illumination and visualization of internal anatomy of a patient within the knee, shoulder, and hip joint. Integrated Endoscopy's Battery Arthroscope has a 141mm working length, an outside diameter of 4mm, a field of view of 105 °, and a direction of 30 °. The Arthroscope is Battery Powered and three selectable light settings. The Arthroscope is designed to be used with a cannula compatible with a 4mm x 30° arthroscope with a working length of 141mm. The Arthroscope is supplied sterile and is for SINGLE USE ONLY. DO NOT REUSE OR RE-STERILIZE.
4
Image /page/4/Picture/0 description: The image contains the logo for Integrated Endoscopy. The logo features the word "integrated" in a lowercase, sans-serif font, followed by the word "endoscopy" in a similar font but with a slightly bolder weight. To the right of the text is a stylized graphic element resembling a triangle or sail, with a gradient that transitions from a light purple at the top to a blue at the bottom. The overall design is clean and modern.
INDICATIONS FOR USE: V.
Integrated Endoscopy's Nuvis® Battery Arthroscope is an endoscopic device introduced into a patient to provide an internal view or image of the interior of a joint for examination, diagnosis, and/or therapy. Integrated Endoscopy's NuVis® Battery Arthroscopes are indicated for use in arthroscopic procedures performed in the knee, shoulder, hip, wrist (carpel tunnel syndrome), temporal mandibular joint, ankle, elbow, and feet (plantar fascia release).
VI. INTENDED USE:
The Nuvis® Battery Arthroscope is intended to be used as an endoscope in arthroscopic procedures performed on the knee, shoulder, hip, wrist (carpel tunnel syndrome), temporal mandibular joint, ankle, elbow, and feet (plantar fascia release) to view the surgical site.
TECHNOLOGY CHARACTERISTICS: VII.
The fundamental scientific technology of the previously cleared predicate device, Integrated Endoscopy NuVis® Arthroscope (K140903) is the same. The Nuvis® Battery Arthroscope utilizes an LED mounted on the inside the long tube of the scope to illuminate the surgical site, which is powered by a non-reusable battery placed within the surgical field.
VIII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The comparison of features and operation principles between Nuvis® Battery Arthroscope and NuVis®Arthroscope from Integrated Endoscopy is listed to below:
| Table 13A. Comparison of Nuvis® Battery Arthroscope to Legally Marketed Predicate |
|---|
| Devices |
| FEATURES AND
SPECIFICATIONS | NUVIS® BATTERY
ARTHROSCOPE
(SUBJECT DEVICE) | NuVis™ ARTHROSCOPE
(PREDICATE DEVICE) | SUBSTANTIALLY
EQUIVALENT
(YES/NO) |
|--------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|
| 510(k) # | K191594 | K140903 | |
| General Information | | | |
| Name of Device | Nuvis Battery Arthroscope | Nuvis Arthroscope | YES |
| Manufacturer | Integrated Endoscopy | Integrated Endoscopy | YES |
| Device Description | Integrated Endoscopy's Battery
Arthroscope is an optical
instrument designed for
illumination and visualization of
internal anatomy of a patient
within the knee, shoulder, and
hip joint. Integrated
Endoscopy's Battery | Integrated Endoscopy's NuVis®
Arthroscope is a non-deflectable
rigid endoscopic optical
instrument designed for
illumination and visualization of
internal anatomy of a patient
within the knee, shoulder, and
hip joint. Integrated | YES |
| FEATURES AND
SPECIFICATIONS | NUVIS® BATTERY
ARTHROSCOPE
(SUBJECT DEVICE) | NuVis™ ARTHROSCOPE
(PREDICATE DEVICE) | SUBSTANTIALLY
EQUIVALENT
(YES/NO) |
| | Arthroscope has a 141mm
working length, an outside
diameter of 4mm, a field of
view of 105°, and a direction of
view of 30°. The Arthroscope is
Battery Powered and three
selectable light settings. The
Arthroscope is designed to be
used with a cannula compatible
with a 4mm x 30° arthroscope
with a working length of
141mm. The Arthroscope is
supplied sterile and is for
SINGLE USE ONLY. DO NOT
REUSE OR RE-STERILIZE. | Endloscopy's NuVis®
Arthroscope has a 140mm
working length, an outside
diameter of 4mm, a field of view
of 105°, and a direction of view
of 30°. The Arthroscope is
designed to be used with a
cannula compatible with a 4mm
x 30° arthroscope with a
working length of 140mm. The
Arthroscope is supplied sterile
and is for Single Use Only. It is
not intended to he re-used or
re-sterilized. | |
| Indications for Use | Integrated Endoscopy's Battery
Arthroscope is an endoscopic
device introduced into a patient
to provide an internal view or
image of the interior of a joint
for examination, diagnosis,
and/or therapy. Integrated
Endoscopy's Battery
Arthroscope is indicated for use
in arthroscopic procedures
performed in the knee,
shoulder, hip, wrist (carpel
tunnel syndrome), temporal
mandibular joint, ankle, elbow,
and feet (plantar fascia release). | Integrated Endoscopy's NuVis®
Arthroscope is an endoscopic
device introduced into a patient
to provide an internal view or
image of the interior of a joint
for examination, diagnosis,
and/or therapy. Integrated
Endoscopy's NuVis®
Arthroscopes are indicated for
use in arthroscopic procedures
performed in the knee,
shoulder, hip, wrist (carpel
tunnel syndrome), temporal
mandibular joint, ankle, elbow,
and feet (plantar fascia release). | YES
(Identical except
for name) |
| Intended Use | The Nuvis Battery Arthroscope
is intended to be used as an
endoscope in arthroscopic
procedures performed on the
knee, shoulder, hip, wrist
(carpel tunnel syndrome),
temporal mandibular joint,
ankle, elbow, and feet (plantar
fascia release) to view the
surgical site. | The Nuvis Arthroscope is
intended to be used as an
endoscope in arthroscopic
procedures performed on the
knee, shoulder, hip, wrist
(carpel tunnel syndrome),
temporal mandibular joint,
ankle, elbow, and feet (plantar
fascia release) to view the
surgical site. | YES
(Identical except
for name) |
| Working Channel Length | 141mm | 140mm | YES |
| Diameter of Working
Channel | 4mm | 4mm | YES |
| FEATURES AND
SPECIFICATIONS | NUVIS® BATTERY
ARTHROSCOPE
(SUBJECT DEVICE) | NuVis™ ARTHROSCOPE
(PREDICATE DEVICE) | SUBSTANTIALLY
EQUIVALENT
(YES/NO) |
| Field of View (FOV) | 105° | 105° | YES |
| Direction/Angle of View
(AOV) | 30° | 30° | YES |
| Principle of Operation | The Nuvis Battery Arthroscope
is essentially a long tube
containing a series of optical
and electrical components. At
the distal end, the primary lens
(lens 1) captures the image of
the object at a 30° angle and
with the aid of two mirrors
transfers the image though a
series of lenses inside the long
tube to the clinician's eye piece
at the proximal end. The image
can be viewed at the Eye Piece
or by a Camera Monitor System
attached to the Eye Piece. | The operation principle of
the NuVis® Arthroscope is
similar to arthroscopes
currently on the market used
for the same indications for
use and intended use. The
major difference is in how
the surgical site is
illuminated. The NuVis®
Arthroscope utilizes an in
built LED that provides light
to illuminate the surgical site
being viewed. Most
Arthroscopes on the market
today incorporate a fiber
bundle that carries the light
from an external light source
connected to it, to the
surgical site. The LED of the
NuVis® Arthroscope is
energized by a custom power
supply located outside the
surgical field as described
earlier in this section. The
LED is connected to the
power supply by means of 10
feet power cable. | YES |
| Method of Operation | The long tube of the endoscope
is inserted into the body
through a surgical incision and
the tip of the scope is placed
above the site that the clinician
wants to visualize. The surgical
site is illuminated by an LED
inside the long tube at the
distal end. | The NuVis® Arthroscope is
essentially a long tube
containing a series of optical
and electrical components. At
the distal end, the primary lens
(lens 1) captures the image of
the object at a 30 ° angle and
with the aid of two mirrors
transfers the image though a
series of lenses inside the long
tube to the clinician's eye piece
at the proximal end. The image
can be viewed at the Eye Piece | YES |
| FEATURES AND
SPECIFICATIONS | NUVIS® BATTERY
ARTHROSCOPE
(SUBJECT DEVICE) | NuVis™ ARTHROSCOPE
(PREDICATE DEVICE) | SUBSTANTIALLY
EQUIVALENT
(YES/NO) |
| | | or by a Camera Monitor System
attached to the Eye Piece. | |
| Sterilization | Supplied Sterile, EO sterilization | Supplied Sterile, EO sterilization | YES |
| Reusable | No, Single Use | No, Single Use | YES |
| General Specifications | | | |
| Resolution (Naked Eye) | 1 to 5 times actual size
depending on distance of distal
tip from site being visualized. | 1 to 5 times actual size
depending on distance of distal
tip from site being visualized. | YES |
| Resolution (Camera
Monitor System) | Dependent on capability of the
Camera Monitor System | Dependent on capability of the
Camera Monitor System | YES |
| Materials of Construction | Stainless Steel, Copper, Glass,
Sapphire, Medical grade
plastics, adhesives | Stainless Steel, Copper, Glass,
Sapphire, Medical grade
plastics, adhesives | YES |
| Biocompatibility of
Materials | Meets ISO 10993-1
requirements | Meets ISO 10993-1
requirements | YES |
| Electrical | | | |
| Light Source | LED | LED | YES |
| Power Supply | AA Alkaline Battery operates at