(51 days)
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.
The Cook® Odyssey Holmium Laser System is used in fragmentation of urinary calculi and soft tissue applications. The Cook® Odyssey Holmium Laser System is a pulsed holmium YAG laser emitting laser radiation at 2100 nm with a 30 Watt maximum average power. The normal wavelength is strongly absorbed by water for tissue ablation with minimal lateral thermal damage. In the case of laser lithotripsy, laser energy vaporizes water in the calculus causing it to crack into small enough particles to pass easily. The system is a completely enclosed transportable unit.
This submission is for a medical device (Cook® Odyssey Holmium Laser System) and focuses on substantial equivalence to predicate devices, rather than establishing performance against specific acceptance criteria through a clinical study involving AI or human reader assessment. Therefore, much of the requested information (e.g., sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, etc.) is not applicable or cannot be extracted from the provided text.
Here is the information that can be gleaned from the provided text, primarily focusing on the regulatory assertion of substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices (VersaPulse® Power Suite, Medilas H 20, Odyssey™ 30 Holmium Laser Systems for intended use) | "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." |
| Meeting Applicable Testing Standards | "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." |
| Indications for Use | Indicated for fragmentation of urinary calculi and soft tissue applications, including Urinary, Gastroenterology, Pulmonary, Gynecology, and General Surgery procedures where fragmentation of stones and soft tissue incision, hemostasis, vaporization, and ablation are indicated. |
| Device Description | Pulsed holmium YAG laser emitting at 2100 nm for tissue ablation with minimal lateral thermal damage, max 30 Watt average power, completely enclosed transportable unit. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The submission describes a regulatory pathway based on substantial equivalence, not a clinical trial with a specific test set of patient data. The "Test Data" mentioned refers to engineering and bench testing to demonstrate compliance with standards, not clinical performance data in human subjects for statistical analysis.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. This is not a study involving expert assessment of medical images or data from a test set. The "ground truth" here is the regulatory equivalence established through technical and functional comparisons to predicate devices.
4. Adjudication Method for the Test Set
Not applicable. No test set requiring expert adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used to evaluate the impact of AI on human reader performance, which is not relevant for this device's 510(k) submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a laser system, not an algorithm or AI product. Its performance is inherent to its physical operation, not an algorithm's standalone analysis.
7. The Type of Ground Truth Used
The "ground truth" in this context is the established safety and effectiveness of the identified predicate devices (VersaPulse® Power Suite, Medilas H 20, Odyssey™ 30 Holmium Laser Systems). The Cook® Odyssey Holmium Laser System's performance and design were compared to these legally marketed devices to demonstrate substantial equivalence, rather than against a specific pathology or outcomes data from a clinical trial.
8. The Sample Size for the Training Set
Not applicable. There is no mention of a training set as this is not an AI-based device and no machine learning model was developed or trained.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set is mentioned.
{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
§ 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.