(86 days)
Not Found
No
The document describes a laser system for surgical procedures and does not mention any AI or ML components or functionalities.
Yes
The device is intended for incision, resection, ablation, vaporization, coagulation, hemostasis of soft tissue, or stone fragmentation, which are therapeutic interventions.
No
The "Intended Use" clearly states that the device is for "incision, resection, ablation, vaporization, coagulation, hemostasis of soft tissue, or stone fragmentation," all of which are treatment or surgical procedures, not diagnostic ones.
No
The device description clearly states it is a "solid-state (i.e., Ho:YAG) laser source unit" and includes physical components like a footswitch pedal and control panel. While software verification and validation are mentioned, the core of the device is hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes surgical procedures (incision, resection, ablation, etc.) performed directly on the patient's body for therapeutic purposes (soft tissue treatment, stone fragmentation).
- Device Description: The device is a laser system that delivers energy to the treatment zone via a fiber. This is a therapeutic device used during surgical interventions.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are specifically designed to perform tests in vitro (outside the living body) on biological samples. This device operates in vivo (within the living body) during surgical procedures.
N/A
Intended Use / Indications for Use
The Rhapsody H-30 Holmium Laser System is intended for incision, resection, ablation, vaporization, coagulation, hemostasis of soft tissue, or stone fragmentation during open surgical, laparoscopic, percutaneous or endoscopic procedures in urologic, gynecologic, gastroenterological, or pulmonary applications.
Product codes
GEX
Device Description
The Rhapsody H-30 Holmium Laser System is an enclosed, transportable solid-state (i.e., Ho:YAG) laser source unit. The laser system unit produces a beam of coherent near-infrared light (2100 nm wavelength) upon activation by depressing a footswitch pedal. The beam is directed to the treatment zone by means of a compatible optical delivery system, such as a holmium laser fiber. Components of the unit include a footswitch pedal and rotatable control panel. The system is a reusable, non-sterile device and is supplied in a wooden shipping crate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urologic, gynecologic, gastroenterological, or pulmonary applications.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Test # RT20110616 H-30 Litho family: Software Verification and Validation: Testing must demonstrate that LCK 1.6 firmware performs as intended. Test results met predetermined criteria.
Test # 28110456-001 IEC 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance: Test article must demonstrate to comply with IEC 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance. Test results met predetermined criteria.
Test # 031714_502_PR #95252 Evaluation of Rhapsody H-30 - Addition of Fan Shroud, Optimization of Cooling Lines and Alignment Procedure: Test articles must demonstrate acceptable output energy within ± 10% of the factory setting and each system must fire for a minimum of 30 minutes at maximum output energy of 2.5J@ 12Hz on short pulse width. Test results met predetermined criteria.
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
§ 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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 26, 2017
Cook Incorporated Colin Jacob Capital Equipment Specialist, Regulatory Affairs 750 Daniels Way P.O. Box 489 Bloomington, Indiana 47402
Re: K172325
Trade/Device Name: Rhapsody H-30 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: Class II Product Code: GEX Dated: July 31, 2017 Received: August 1, 2017
Dear Colin Jacob:
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. 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820):
1
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 contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/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 Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely, Jennifer R. Stevenson -53 For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K172325
Device Name Rhapsody H-30 Holmium Laser System
Indications for Use (Describe)
The Rhapsody H-30 Holmium Laser System is intended for incision, resection, ablation, vaporization, coagulation, hemostasis of soft tissue, or stone fragmentation during open surgical, laparoscopic, percutaneous or endoscopic procedures in urologic, gynecologic, gastroenterological, or pulmonary applications.
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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Image /page/3/Picture/0 description: The image shows the Cook Medical logo, which is white text on a red background. The word "COOK" is in large, bold letters at the top. Below that, the word "MEDICAL" is in smaller letters. Below the logo is the text "510(k) Summary" in a large, bold font.
COOK
INCORPORATED
750 DANIELS WAY, P.O. BOX 489
BLOOMINGTON, IN 47402-0489 U.S.A.
PHONE: 812.339.2235 TOLL FREE: 800.457.4500
WWW.COOKMEDICAL.COM
Rhapsody H-30 Holmium Laser System (21 CFR § 878.4810) Date Prepared: October 26, 2017
Submitted By:
| Applicant: | Cook Incorporated |
|---|---|
| Contact: | Colin S. Jacob |
| Applicant Address: | Cook Incorporated |
| P.O. Box 489 | |
| 750 Daniels Way | |
| Bloomington, IN 47402 | |
| Contact Phone Number: | (812) 335-3575 x 104965 |
| Contact Fax Number: | (812) 332-0281 |
Device Information:
| Trade Name: | Rhapsody H-30 Holmium Laser System |
|---|---|
| Common Name: | Powered Laser Surgical Instrument |
| Classification Name/Panel: | General & Plastic Surgery |
| Regulation: | 21 CFR § 878.4810 |
| Product Code: | GEX |
Predicate Devices:
- . H-30 Holmium Laser System (K130444)
Device Description:
The Rhapsody H-30 Holmium Laser System is an enclosed, transportable solid-state (i.e., Ho:YAG) laser source unit. The laser system unit produces a beam of coherent nearinfrared light (2100 nm wavelength) upon activation by depressing a footswitch pedal. The beam is directed to the treatment zone by means of a compatible optical delivery system, such as a holmium laser fiber. Components of the unit include a footswitch pedal and rotatable control panel. The system is a reusable, non-sterile device and is supplied in a wooden shipping crate.
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Image /page/4/Picture/0 description: The image shows the logo for Cook Medical. The logo is a red rectangle with the word "COOK" in white, sans-serif font. Below the word "COOK" is the word "MEDICAL" in a smaller, white, sans-serif font. The bottom left corner of the rectangle is cut off at an angle.
COOK INCORPORATED
750 DANIELS WAY, P.O. BOX 489
BLOOMINGTON, IN 47402-0489 U.S.A.
PHONE: 812.339.2235 TOLL FREE: 800.457.4500
Indications for Use:
The Rhapsody H-30 Holmium Laser System is intended for incision, excision, resection, ablation, vaporization, coagulation, hemostasis of soft tissue, or stone fragmentation during open surgical, laparoscopic, percutaneous or endoscopic procedures in urologic, gynecologic, gastroenterological, or pulmonary applications.
Comparison to Predicate Devices:
The Rhapsody H-30 Holmium Laser System and the predicate device, H-30 Holmium Laser System (K130444), are substantially equivalent in that these devices have the same intended use and principles of operation. The differences in technological characteristics (i.e., software and minor internal components) do not raise different questions of safety and/or effectiveness when comparing to the predicate device.
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Image /page/5/Picture/0 description: The image shows the Cook Medical logo. The word "COOK" is in white, sans-serif font on a red background. Below the word "COOK" is the word "MEDICAL" in white, sans-serif font on a red background.
COOK INCORPORATED 750 DANIELS WAY, P.O. BOX 489 BLOOMINGTON, IN 47402-0489 U.S.A. PHONE: 812.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM
Comparison to Predicate Device
| PRIMARY PREDICATE | SUBJECT DEVICE | |
|---|---|---|
| H-30 Holmium Laser System | Rhapsody H-30 Holmium Laser System | |
| 510(k) | K130444 | Subject of submission |
| Manufacturer | Cook Incorporated | Cook Incorporated |
| Regulation | 21 CFR § 878.4810 | |
| General & Plastic Surgery | IDENTICAL TO PREDICATE | |
| Product Code | GEX | IDENTICAL TO PREDICATE |
| Classification | Powered Laser Surgical Instrument | IDENTICAL TO PREDICATE |
| Indications for Use | The H-30 Holmium Laser System is indicated for use in fragmentation of urinary calculi and soft tissue applications. The H-30 Holmium Laser System is indicated for use in urinary procedures where fragmentation of stones and soft tissue incision, hemostasis, vaporization, and ablation are indicated. | The Rhapsody H-30 Holmium Laser System is intended for incision, excision, resection, ablation, vaporization, coagulation, hemostasis of soft tissue, or stone fragmentation during open surgical, laparoscopic, percutaneous or endoscopic procedures in urologic, gynecologic, gastroenterological, or pulmonary applications. |
| Principles of Operation | Generates pulsed laser energy for delivery to the surgical site via silica core laser fibers | IDENTICAL TO PREDICATE |
| Fundamental Scientific Technology | Solid-state, holmium yttrium aluminum garnet (Ho:YAG), pulsed laser operating at 2100 nanometers | IDENTICAL TO PREDICATE |
| PRIMARY PREDICATE | SUBJECT DEVICE | |
| H-30 Holmium Laser System | Rhapsody H-30 Holmium Laser System | |
| Technological Characteristics | ||
| Laser Wavelength | 2100 nm | IDENTICAL TO PREDICATE |
| Maximum Output | 30 W | IDENTICAL TO PREDICATE |
| Repetition Rate | 5 to 20 Hz | IDENTICAL TO PREDICATE |
| Visible Aiming Beam | Variable Intensity |