(51 days)
Not Found
No
The document describes a laser system for fragmentation and ablation, with no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is used for medical procedures like fragmentation of urinary calculi and soft tissue applications, directly treating medical conditions.
No
The device is used for therapeutic procedures such as fragmentation of urinary calculi and soft tissue applications, not for diagnosing conditions.
No
The device description explicitly states it is a "pulsed holmium YAG laser emitting laser radiation at 2100 nm with a 30 Watt maximum average power" and a "completely enclosed transportable unit," indicating it is a hardware device.
Based on the provided information, the Cook® Odyssey Holmium Laser System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the device is for "fragmentation of urinary calculi and soft tissue applications" and is used in various surgical procedures. This involves direct interaction with the patient's body for therapeutic purposes (breaking stones, cutting tissue).
- Device Description: The description details a laser system that emits radiation to interact with tissue and stones. This is a physical intervention, not a test performed on a sample taken from the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis
IVD devices are designed to perform tests on samples taken from the human body to provide information about a person's health. The Cook® Odyssey Holmium Laser System is a surgical tool used for treatment and intervention within the body.
N/A
Intended Use / Indications for Use
The Cook® Odyssey Holmium Laser System is indicated for use in fragmentation of urinary calculi and soft tissue applications. The Cook® Odyssey Holmium Laser System is indicated for use in Urinary, Gastroenterology, Pulmonary, Gynecology, and General Surgery procedures where fragmentation of stones and soft tissue incision, hemostasis, vaporization and ablation are indicated.
Product codes
GEX
Device Description
The Cook® Odyssey Holmium Laser System is used in fragmentation of urinary calculi and soft tissue applications. The Gooks Ouyers, Trentify and a 30 Watt maximum average YAG laser eintiting faser radiation at in the released by water for tissue ablation with power. The normall wavelongth to mgmy aboved lithotripsy, laser energy waporizes minimal lateral thermal damage. In the bace of last whough particles to pass easily water in the calculus causing it to cranadio mee commiss a completely enclosed transportable unit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Applicable testing was performed in accordance with United States Food and Drug Administration recommendations and recognized national and international standards. Testing data and information is included in this submission. All testing results were acceptable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
VersaPulse® Power Suite (KUTT/US), Medilas H 20 (K061455), Odyssey ™ 30 (K951910)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. 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 § 878.9.
0
Cook® Odyssey Holmium Laser System STED 510(k) submission Cook Urological, Incorporated February 15, 2008
510(k) SUMMARY
Submitted by:
1080525
APR 1 7 2008
Cindy Foote Regulatory Affairs Specialist Cook Urological, Incorporated 750 Daniels Way P.O. Box 489 Bloomington, Indiana 47402-0489 February 15, 2007
Device:
Trade Name:
Cook® Odyssey Holmium Laser System
Proposed Classification Name:
Laser Instrument, Surgical, Powered 21 CFR Part 878.4810 Class II, GEX Class IV Laser Product
Predicate Devices:
The Cook® Odyssey Holmium Laser System is similar with respect to indications for use The Cook® Odyssey Fromilant Laser Oyclom is annumercial distribution Specifically, the and technology to existing prodiouts do resormlar to the VersaPulse® Power Suite Cooke Odyssey Hollnium Laser Oysten is online by Boston Scientific Corporation and the (KUTT/US) manufactured by Lambile, alothbuter Med Tech, distributed by Gyrus ACMI.
Medilas H 20 (K061455) manufactured by Donier Med Tech, distributed by Dyrus 1910 Medilas H 20 (K00 1455) maintiablarou by Dornier in the Odyssey ™ 30 (K951910) The Cook® Odyssey Holmann Laser Oyoten is lashtour of the issues on distributed by Cook Urological, Incorporated.
Device Description:
The Cook® Odyssey Holmium Laser System is used in fragmentation of urinary calculi and The Cook® Odyssey Holmidm Laser System is assum is assem is a pulsed holmium success soft tissue applications. The Gooks Ouyers, Trentify and a 30 Watt maximum average YAG laser eintiting faser radiation at in the released by water for tissue ablation with power. The normall wavelongth to mgmy aboved lithotripsy, laser energy waporizes minimal lateral thermal damage. In the bace of last whough particles to pass easily water in the calculus causing it to cranadio mee commiss a completely enclosed transportable unit.
Company Confidential Cook Urological
રૂક
1
Cook® Odyssey Holmium Laser System STED 510(k) submission Cook Urological, Incorporated February 15, 2008
Substantial Equivalence:
The Cook® Odyssey Holmium Laser System is comparable with respect to intended use to the published predicate device description and meets the requirements for 510(k) substantial equivalence.
Test Data:
Applicable testing was performed in accordance with United States Food and Drug Administration recommendations and recognized national and international standards. Testing data and information is included in this submission. All testing results were acceptable.
Company Confidential Cook Urological
P
ਤਰੇ
2
Cook® Odyssey Holmium Laser System STED 510(k) submission Cook Urological, Incorporated February 15, 2008
Substantial Equivalence:
The Cook® Odyssey Holmium Laser System is comparable with respect to intended use to the published predicate device description and meets the requirements for 510(k) substantial equivalence.
Test Data:
Applicable testing was performed in accordance with United States Food and Drug Administration recommendations and recognized national and international standards. Testing data and information is included in this submission. All testing results were acceptable.
Company Confidential Cook Urological
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract eagle or bird-like figure, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 7 2008
Cook Urological, Inc. % Ms. Cindy Foote Regulatory Affairs Specialist 750 Daniels Way Bloomington, Indiana 47404
Re: K080525
Trade/Device Name: Cook® Odyssey Holmium Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: April 1, 2008 Received: April 2, 2008
Dear Ms. Foote:
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
4
Page 2 - Ms. Cindy Foote
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.
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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket, Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark M. Millman
Mark N. Melkerson · Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
| 510(k) Number (if known): | K080525 |
|---|---|
| Device Name: | Cook ® Odyssey Holmium Laser System |
| Indications for Use: | Indicated for use in fragmentation of urinary calculi and soft tissue applications. The Cook® Odyssey Holmium Laser System is indicated for use in Urinary, Gastroenterology, Pulmonary, Gynecology, and General Surgery procedures where fragmentation of stones and soft tissue incision, hemostasis, vaporization and ablation are indicated. |
Prescription Use_ × (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 IF NEEDED)
Concurrence of GDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K080525