(98 days)
No
The description focuses on the optical and mechanical components of the arthroscope and does not mention any software, image processing, or AI/ML capabilities.
No.
Explanation: The device is described as an endoscopic device used for providing an internal view for examination, diagnosis, and/or therapy, but it does not directly administer therapy itself; it merely facilitates the viewing component of a therapeutic procedure.
Yes
The "Intended Use / Indications for Use" section explicitly states that Stryker Arthroscopes are used for "examination, diagnosis, and/or therapy." This clearly indicates a diagnostic function for the device.
No
The device description clearly details a physical, invasive medical device (an endoscope) made of materials like stainless steel, titanium, and glass, which is introduced into a patient's body. This is not a software-only device.
Based on the provided information, the Stryker Arthroscope is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
- Stryker Arthroscope's Function: The description clearly states that the Stryker Arthroscope is an endoscopic device introduced into a patient to provide an internal view or image of the interior of a joint. It is used for direct visualization within the body.
- No Specimen Examination: There is no mention of the device being used to examine specimens outside of the body.
Therefore, the Stryker Arthroscope falls under the category of a surgical endoscope used for direct visualization and intervention within the body, not an IVD.
N/A
Intended Use / Indications for Use
Stryker Arthroscopes are endoscopic devices introduced into a patient to provide an internal view or image of the interior of a joint for examination, diagnosis, and/or therapy. Arthroscopes are indicated for use in arthroscopic procedures performed in the hip, knee, shoulder, wrist (carpel tunnel syndrome), temporal mandibular joint, ankle, elbow, and feet (plantar fascia release).
Product codes
HRX
Device Description
Stryker Arthroscopes are endoscopic devices introduced into a patient to provide an internal view or image of the interior of a joint for examination, diagnosis, and/or therapy. The Stryker Arthroscope is a long tube containing a series of lenses. At the distal end, an objective lens captures the image of the object. Lens along the rod relay the image. At the proximal end, a proximal coupling lens relays the image to a CCD (Camera).
The Stryker Arthroscopes come in various diameters including 1.9mm, 2.7mm, and 4.0mm. Larger size arthroscopes are used for general viewing, while smaller diameter arthroscopes are used for restricted surgical sites. The Stryker Arthroscopes come in several directions of view including, 0°, 30°,45°, 70°. The direction of view enables viewing of different parts. Materials of the Arthroscope include stainless steel, titanium, PEEK, Glass, and Sapphire.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hip, knee, shoulder, 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 subject device has been subjected to and passed electrical safety, sterilization, and biocompatibility testing requirements. The patient contacting materials are identical to the materials used in the predicated device (Henke Sass Wolf Arthroscope K080560). The Stryker Arthroscopes met all specified design and performance requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
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5900 Optical Court San Jose, CA 95138 1: 408 754 2000 f: 408 754 2521
K093677
MAR - 5 2010
stryker®
Endoscopy
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Device Name Proprietary Name: Common and Usual Names: Classification Name:
Stryker Arthroscope Stryker Arthroscope Arthroscope (21 CFR § 888.1100, Product Code HRX)
Intended Use: Stryker Arthroscopes are endoscopic devices introduced into a patient to provide an internal view or image of the interior of a joint for examination, diagnosis, and/or therapy. Arthroscopes are indicated for use in arthroscopic procedures performed in the hip, knee, shoulder, wrist (carpel tunnel syndrome), temporal mandibular joint, ankle, elbow, and feet (plantar fascia release).
Device Description: Stryker Arthroscopes are endoscopic devices introduced into a patient to provide an internal view or image of the interior of a joint for examination, diagnosis, and/or therapy. The Stryker Arthroscope is a long tube containing a series of lenses. At the distal end, an objective lens captures the image of the object. Lens along the rod relay the image. At the proximal end, a proximal coupling lens relays the image to a CCD (Camera).
The Stryker Arthroscopes come in various diameters including 1.9mm, 2.7mm, and 4.0mm. Larger size arthroscopes are used for general viewing, while smaller diameter arthroscopes are used for restricted surgical sites. The Stryker Arthroscopes come in several directions of view including, 0°, 30°,45°, 70°. The direction of view enables viewing of different parts. Materials of the Arthroscope include stainless steel, titanium, PEEK, Glass, and Sapphire.
Technological Characteristics: The Stryker Arthroscopes are substantially equivalent in construction and materials to the predicate Henke Sass Wolf Arthroscopes (K080560).
| | Proposed Device | Predicate Device | Equivalence | Impact on
Safety and
Effectiveness |
|----------------------------------------|---------------------|-------------------------|-------------|-------------------------------------------------------------------------------------------------------------|
| Device | Stryker Arthroscope | HSW Arthroscope | | |
| Technological Characteristics (Design) | | | | |
| Field of View
(FOV),
Degrees | 105°, 80°, 65° | 85°, 105° | Different | The differences
in the Field of
view do not
affect the
safety and
efficacy of the
device. |
| Direction of
View | 0°, 30°, 45°, 70° | 0°, 30°, 45°, 70°, 110° | Same | N/A |
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1
| Outer
Diameter | 4mm, 2.7mm, 2.3mm,
1.9mm | 4mm, 2.3mm-2.9mm,
1.7-1.9mm | Same | N/A |
|----------------------------|------------------------------------------|-----------------------------------------|-----------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Working
Length | 165mm, 140mm, 120mm,
75mm, 72mm, 58mm | 195mm, 185mm,
140mm, 70mm, 60mm | Different | The lengths are
within the
range of the
predicate. The
differences in
the length do
not affect the
safety and
efficacy of the
device. |
| Single Use or
Reusable | Reusable | Reusable | Same | Equivalent |
| Light Guide
End Adapter | Storz and Olympus | ACMI, Storz, Olympus,
Wolf & Dyonics | Same | N/A |
Voluntary Safety and Performance Standards: The Stryker Arthroscopes conform to the voluntary standards including but not limited to (Refer to Section 5.1):
Biological Evaluation of Medical Devices
10993-1: Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing
10993-10: Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Delayed-Type Hypersensitivity
Electrical Safety Requirements Per 60601
IEC 60601-1: Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
IEC 60601-2-18: Medical Electrical Equipment - Part 2: Particular Requirements for the safety of endoscopic equipment
AAMI/ISO Standards for Sterilization of Medical Devices
TIR 12: Designing, Testing and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities
ISO 14937: Sterilization of Health Care Products - General Requirements for Characterization of a Sterilizing Agent and the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices
Optics
ISO 8600-1: Optics and photonics - Medical endoscopes and endotherapy devices - Part 1: General requirements
ISO 8600-3: Optics and optical instruments: Medical endoscopes and endoscopic accessories Part 3: Determination of field of view and direction of view of endoscopes with optics
ISO 8600-5: Optics and photonics-Medical Endoscopes and Endoscopic Accessories-Part 5: Determination of Optical Resolution of rigid endoscopes with optics.
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Performance Testing: The subject device has been subjected to and passed electrical safety, sterilization, and biocompatibility testing requirements. The patient contacting materials are identical to the materials used in the predicated device (Henke Sass Wolf Arthroscope K080560). The Stryker Arthroscopes met all specified design and performance requirements.
Predicate Devices: The Stryker Arthroscopes are substantially equivalent in terms of safety and effectiveness to the currently marketed device, Henke Sass Wolf Arthroscopes (K080560).
Substantial Equivalence: The technological differences between the Stryker Arthroscope and Henke Sass Wolf Arthroscopes do not raise new questions of safety or effectiveness. Therefore the Stryker Arthroscopes are substantially equivalent to the previously cleared Henke Sass Wolf Arthroscope (K080560). Refer to Section 7.0 for a detailed comparison.
Contact:
Signature
Feb. 25, 2010
Shibir Desai Stryker Endoscopy 5900 Optical Court San Jose, CA 92138 Phone: 408-754-2784 408-754-2521 Fax: Email: Shibir.Desai@stryker.com Date:
പ്ര
3
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) in the United States. The logo features the HHS emblem, which includes a stylized depiction of an eagle with outstretched wings. The emblem is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR - 5 2010
Stryker Endoscopy % Shibir Desai Regulatory Affairs Analyst 5900 Optical Court San Jose, California 95136
Re: K093677
Trade/Device Name: Stryker Arthroscope Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: February 25, 2010 Received: March 2, 2010
Dear Shibir Desai:
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. Iisting 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Shibir Desai
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 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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INTENDED USE
Device Name: Stryker Arthroscope
K093677 510(k) Number if known:
Stryker Arthroscopes are endoscopic devices introduced into a patient to provide an internal view or image of the interior of a joint for examination, diagnosis, and/or therapy. Arthroscopes are indicated for use in arthroscopic procedures performed in the hip, knee, shoulder, wrist (carpel tunnel syndrome), temporal mandibular joint, ankle, elbow, and fect (plantar fascia release).
No known contraindications.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nelkell
(Division Sign-Off) for nxim
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093677
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