(51 days)
Not Found
No
The summary describes a standard rigid endoscope with image processing capabilities, but there is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies. The predicate device is an imaging system, which is consistent with the described functionality.
No.
The device description states its use is for visualization and imaging for examination, diagnosis, or therapy, indicating it is an imaging tool rather than a device that provides therapy itself.
Yes
The device description states that the SPY Laparoscope is used "for examination, diagnosis or therapy," directly indicating a diagnostic purpose.
No
The device description explicitly states it is a "tubular optical instrument" and part of a "rigid endoscope product portfolio," indicating it is a physical hardware device used for visualization. While it mentions image processing, this is done by a separate camera system, and the core device itself is hardware.
Based on the provided information, the SPY Laparoscope is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for visualizing or imaging a patient's anatomy during minimally invasive procedures for examination, diagnosis, or therapy. This is a direct interaction with the patient's body for real-time visualization, not the analysis of samples taken from the body.
- Device Description: The description clearly states it's a tubular optical instrument used to visualize and image anatomy during procedures. It transmits light and relays images of the surgical site.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The SPY Laparoscope does not perform this function.
The SPY Laparoscope is a medical device used for visualization and imaging in vivo (within the body) during surgical procedures.
N/A
Intended Use / Indications for Use
The SPY Laparoscope is intended to be used for gynecological and general procedures that clinicians deem appropriate for the adult or pediatric patient aged one month or older, when the dimensions of the SPY Laparoscope are appropriate for the patient size and anatomy.
Product codes
GCJ, FCW
Device Description
Stryker's SPY Laparoscope is part of Stryker's rigid endoscope product portfolio. Stryker's SPY Laparoscopes are tubular optical instruments used to visualize or image a patient's anatomy during minimally invasive, endoscopic procedures for examination, diagnosis or therapy. The SPY Laparoscope transmits light in both the visible and near infrared spectrum to illuminate and image the anatomy, then forms and relays the image of the surgical site to a camera system for processing and display.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult or pediatric patient aged one month or older
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 following performance data were provided in support of the substantial equivalence determination.
| Test | Method | Result |
|---|---|---|
| Electrical Safety | ● IEC 60601-1:2005 + A1:2012 ● IEC 60601-2-18:2009 | PASS |
| Packaging | ● ASTM D4169:2016 | PASS |
| Biocompatibility | ● ISO 10993-1:2018 ● ISO 10993-5:2009 ● ISO 10993-10:2010 ● ISO 10993-11:2017 ● FDA Guidance: Use of International Standard ISO 10993-1 | PASS |
| Cleaning & Disinfection | ● AAMI TIR 12:2020 ● AAMI TIR 30:2011 ● ISO 15883-5:2021 ● ISO 15883-2:2009 ● ISO 15883-1:2009 | PASS |
| Sterilization | ● AAMI ST79:2017 ● AAMI ST58:2013 ● AAMI TIR 12:2020 ● ISO 17665-1:2021 ● ISO 14937:2009 ● FDA Guidance: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling | PASS |
| Performance - Bench | ● Optical and mechanical verification in accordance with device input specifications and comparison to predicate device ● ISO 8600-1:2015 | PASS |
| Design Validation | ● IEC 62366-1:2020 ● In accordance with device user needs | PASS |
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
Not Found
§ 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.
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June 17, 2022
Stryker Christie Samsa Manager, Regulatory Affairs 5900 Optical Court San Jose, California 95138
Re: K221217
Trade/Device Name: SPY Laparoscope Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ, FCW Dated: April 25, 2022 Received: April 27, 2022
Dear Christie Samsa:
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/cfpm/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.
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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 and Part 809); medical device reporting (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
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Indications for Use
510(k) Number (if known) K221217
Device Name SPY Laparoscope
Indications for Use (Describe)
The SPY Laparoscope is intended to be used for gynecological and general procedures that clinicians deem appropriate for the adult or pediatric patient aged one month or older, when the dimensions of the SPY Laparoscope are appropriate for the patient size and anatomy.
| 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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510(k) Summary
This 510(k) Summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 C.F.R Part 807.92(c)
Submitter:
| Applicant | Stryker Endoscopy
5900 Optical Court
San Jose, CA 95138 |
|----------------|-------------------------------------------------------------------------------------------------------------|
| Contact Person | Christie Samsa
Manager, Regulatory Affairs
Phone: (978) 500-1303
Email: christie.samsa@stryker.com |
| Date Prepared | June 9, 2022 |
Subject Device:
| Name of Device | SPY Laparoscope |
|---|---|
| Common or Usual Name | Laparoscope |
| Classification Name | Endoscope And Accessories, 21 C.F.R. §876.1500 |
| Regulatory Class | Class II |
| Product Code | GCJ |
Predicate Device:
| Name of Device | Stryker AIM (Advanced Imaging Modality) System, K210088 |
|---|---|
| ---------------- | --------------------------------------------------------- |
NOTE: The predicate device has not been subject to a design-related recall.
Device Description:
Stryker's SPY Laparoscope is part of Stryker's rigid endoscope product portfolio. Stryker's SPY Laparoscopes are tubular optical instruments used to visualize or image a patient's anatomy during minimally invasive, endoscopic procedures for examination, diagnosis or therapy. The SPY Laparoscope transmits light in both the visible and near infrared spectrum to illuminate and image the anatomy, then forms and relays the image of the surgical site to a camera system for processing and display.
4
Indications for Use:
The SPY Laparoscope is intended to be used for gynecological and general procedures that clinicians deem appropriate for the adult or pediatric patient aged one month or older, when the dimensions of the SPY Laparoscope are appropriate for the patient size and anatomy.
| Feature | Subject Device | Predicate Device |
|---|---|---|
| SPY Laparoscope | ||
| (Current Submission) | Stryker AIM (Advanced Imaging | |
| Modality) System | ||
| (K210088) | ||
| Manufacturer | Stryker Endoscopy | Same as subject device |
| Submission Reference | Current Submission | K210088 |
| Intended Use | Endoscopic white light and near-infrared | |
| illumination and imaging during | ||
| endoscopic procedures. | Same as subject device | |
| Indications for Use Statement | The SPY Laparoscope is intended to be | |
| used for gynecological and general | ||
| procedures that clinicians deem | ||
| appropriate for the adult or pediatric | ||
| patient aged one month or older, when | ||
| the dimensions of the SPY Laparoscope | ||
| are appropriate for the patient size and | ||
| anatomy. | Same as subject device | |
| Image Transmission | Rigid rod lenses | Same as subject device |
| Outer diameter | 5.4mm, 10mm | Same as subject device |
| Working Length | 30cm, 33cm & 45cm | 30cm, 33cm |
| DOV | 0°, 30°, 45° | 0°, 30° |
| FOV | 75° | Same as subject device |
| Patient-Contacting Materials | Stainless Steel, Epoxy, Optical Glass | |
| (sapphire), Glass Fibers | Same as subject device | |
| Single Use or Reusable | Reusable | Same as subject device |
| Cleaning | Manual and Automated | Same as subject device |
| Disinfection | Manual and Automated | Same as subject device |
| Sterilization | ||
| Methods | Autoclave, Steris VPRO, | |
| Sterrad | Same as subject device | |
| Sterility Assurance Level | $10^{-6}$ | $10^{-6}$ |
Comparison of Technological Characteristics with the Predicate Device:
5
Performance Testing:
The following performance data were provided in support of the substantial equivalence determination.
| Test | Method | Result |
|---|---|---|
| Electrical Safety | ● IEC 60601-1:2005 + A1:2012 | PASS |
| ● IEC 60601-2-18:2009 | ||
| Packaging | ● ASTM D4169:2016 | PASS |
| Biocompatibility | ● ISO 10993-1:2018 | PASS |
| ● ISO 10993-5:2009 | ||
| ● ISO 10993-10:2010 | ||
| ● ISO 10993-11:2017 | ||
| ● FDA Guidance: Use of International Standard ISO 10993-1 | ||
| Cleaning & | ||
| Disinfection | ● AAMI TIR 12:2020 | PASS |
| ● AAMI TIR 30:2011 | ||
| ● ISO 15883-5:2021 | ||
| ● ISO 15883-2:2009 | ||
| ● ISO 15883-1:2009 | ||
| Sterilization | ● AAMI ST79:2017 | PASS |
| ● AAMI ST58:2013 | ||
| ● AAMI TIR 12:2020 | ||
| ● ISO 17665-1:2021 | ||
| ● ISO 14937:2009 | ||
| ● FDA Guidance: Reprocessing Medical Devices in Health Care Settings: | ||
| Validation Methods and Labeling | ||
| Performance - | ||
| Bench | ● Optical and mechanical verification in accordance with device input | |
| specifications and comparison to predicate device | PASS | |
| ● ISO 8600-1:2015 | ||
| Design Validation | ● IEC 62366-1:2020 | PASS |
| ● In accordance with device user needs |
Conclusions:
The SPY Laparoscope is the same or similar in design, intended use, principles of operation, technological characteristics and safety features to the predicate device. There are no new issues of safety and/or effectiveness introduced by the SPY Laparoscope when used as instructed.