(85 days)
Model Number 0010-2400 is a fiber optic delivery device intended for use with the GreenLight™ XPS Laser System for its FDA cleared indications for use.
Model Number 0010-2400 is supplied as a single-use, sterile product and is compatible with the GreenLight™ XPS Laser System. It can access the tissue in multiple planes. Model Number 0010-2400 is a liguid cooled delivery device which enables the delivery of up to 180W of power and aids in maintaining a clear environment at the fiber cap.
The provided document describes a 510(k) premarket notification for a medical device, the American Medical Systems Model Number 0010-2400 GreenLight MoXy™ Fiber Optic. This is a special 510(k) submission, indicating a modification to an already cleared device, the Fiber One (K100746). The submission focuses on demonstrating substantial equivalence to the predicate device, rather than a de novo approval.
As such, the document does not contain information related to a clinical study with acceptance criteria, reported device performance, sample sizes, ground truth establishment, or expert involvement in the way one would expect for a new or significantly modified device requiring such studies. The assessment here is based on non-clinical (bench) testing and comparison of technological characteristics to the predicate device.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the traditional sense of a clinical trial. Instead, the "acceptance criteria" for this Special 510(k) are implied by demonstrating that the modified device (Model 0010-2400) maintains substantial equivalence to the predicate device (Fiber One) through non-clinical testing and comparison of specifications.
| Characteristic / "Acceptance Criteria" Metric | Predicate Device (Fiber One) Performance | Modified Device (Model 0010-2400) Performance |
|---|---|---|
| K Number | K100746 | K120870 (reference number for this submission) |
| Regulation Number | 21 CFR§878.4810 | 21 CFR§878.4810 |
| Regulation Name | Laser surgical instrument for use in general and plastic surgery and in dermatology | Laser surgical instrument for use in general and plastic surgery and in dermatology |
| Classification | Class II | Class II |
| Product Code | GEX | GEX |
| Laser System Compatibility | GreenLight XPS Laser System | GreenLight XPS Laser System |
| Endoscope/Cystoscope Compatibility | 22 to 24 Fr continuous flow | 22 to 24 Fr continuous flow |
| Saline flow | ≥0.3mL/sec | ≥0.3mL/sec |
| Fiber and Cap Assembly Outer Diameter | <2.3 mm | <2.3 mm |
| Total Length | 305cm | 305cm |
| Operation Length | 36cm | 36cm |
| Fiber Core Size | 750μm | 750μm |
| Internal Fiber Cooling | Yes | Yes |
| Max. Laser Power | 180W | 180W |
| Energy Limit | 400kJ | 650kJ |
| Beam Area at 2 mm | 0.48mm² | 0.48mm² |
| Power Density at 2 mm (180W) | 326W/mm² | 326W/mm² |
| Power Density at 2 mm (120W) | 218W/mm² | 218W/mm² |
| Materials | 304 stainless steel, polyamide, silica glass | 304 stainless steel, polyamide, silica glass |
| Sterilization | Ethylene Oxide | Ethylene Oxide |
| Dating (Shelf Life) | 2 years, accelerated | 2 years, accelerated |
| Storage Conditions | 4 to 40 °C, keep dry | 4 to 40 °C, keep dry |
| Metal Cap | Initial design | Minor tolerance refinements to increase process capability |
| Labeling, IFU | Released at Rev B | Clarifications to instructions, use and improved caution statements, 2 additional languages added |
| ETO Residue (EO) | Max reported: 2.57 mg/device (for predicate) | Max reported: 2.57 mg/device (for predicate) |
| ETO Residue (ECH) | Max reported: 1.47 mg/device (for predicate) | Max reported: 1.47 mg/device (for predicate) |
| ISO 10993-7:2008 EO Limit | <4 mg/device (implicit acceptance) | <4 mg/device (met by modified device) |
| ISO 10993-7:2008 ECH Limit | <9 mg/device (implicit acceptance) | <9 mg/device (met by modified device) |
Note: The increase in "Energy Limit" from 400kJ to 650kJ is a modification presented, but the document does not elaborate on specific testing or acceptance criteria related to this increase beyond general bench testing for substantial equivalence. The "Metal Cap" and "Labeling, IFU" changes are noted as post-510k changes that didn't trigger a new 510k.
2. Sample Size Used for the Test Set and Data Provenance
The document states, "All necessary bench testing was conducted on the Model Number 0010-2400 to support a determination of substantial equivalence to the predicate device."
Regarding sterilization residue testing, a table is provided for the predicate device (Fiber One), showing 9 samples tested over 3 days (Day 1, 2, 3 with A, B, C runs each day).
- Sample Size for Sterilization Residue (Predicate): 9 units (tested over 3 days for EO and ECH)
- Data Provenance: The sterilization residue data is explicitly stated to be "extracted from the original 510k for Fiber One (MoXy) K100746, Appendix 3: Sterilization, page 12 of 15, Table 6." This indicates the data is retrospective for the predicate device. For the modified device, it states, "Model 0010-2400 is the same as Fiber One device and uses the same sterilization cycle and meets the ISO 10993-7:2008 recommendations..." implying the pre-existing data and methodology were deemed sufficient.
- Country of origin of data: Not specified, but given the submitter's address (San Jose, CA, U.S.A.) and the FDA context, it's highly likely to be US-based or to US standards.
No other specific "test set" sample sizes are provided for other non-clinical tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This section is Not Applicable to the provided document. The submission relies on non-clinical bench testing and comparison to technical specifications, not a clinical study involving experts establishing ground truth for a test set.
4. Adjudication Method for the Test Set
This section is Not Applicable. There was no clinical test set requiring adjudication in the context of this 510(k) submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This section is Not Applicable. The device is a surgical fiber optic (hardware), not an AI diagnostic or assistance tool. Therefore, no MRMC study or AI-related effectiveness analysis was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This section is Not Applicable. The device is a surgical fiber optic, not an algorithm.
7. The Type of Ground Truth Used
For the sterilization residue testing, the "ground truth" or reference criteria used were the ISO 10993-7:2008 recommendations for limited exposure values for Ethylene Oxide (EO) and Ethylene Chlorohydrin (ECH).
- EO Limit: <4 mg/device
- ECH Limit: <9 mg/device
For other characteristics, the "ground truth" is adherence to the technical specifications of the predicate device or, where modifications occurred (e.g., energy limit, metal cap design), that these changes do not raise new questions of safety or effectiveness and maintain compatibility/functionality. This is essentially a technical specification and regulatory standard adherence "ground truth."
8. The Sample Size for the Training Set
This section is Not Applicable. This is a hardware medical device submission, not an AI/machine learning model, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set was Established
This section is Not Applicable. As there is no training set, there is no ground truth establishment for one.
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AMERICAN MEDICAL SYSTEMS
Model Number 0010-2400 SPECIAL 510(K)
SECTION 7 510(K) SUMMARY [21 CFR 807.92]
510(k) Notification K120870
SUBMITTER'S NAME AND ADDRESS
Doreen Nakamura Senior Regulatory Affairs Specialist American Medical Systems Innovation Center - Silicon Valley 3070 Orchard Drive San Jose, CA 95134 U.S.A. Phone: 408-445-3441 Fax: 408-943-9630 Email: Doreen.Nakamura@AmericanMedicalSystems.com
DATE SUMMARY WAS PREPARED
June 14, 2012
DEVICE TRADE/PROPRIETARY NAME GreenLight MoXyTM Fiber Optic
DEVICE COMMON/ USUAL NAMES Laser surgical instrument for use in general and plastic surgery and in dermatology
DEVICE CLASSIFICATION NAMES Powered Laser Surgical Instrument
PRODUCT CODE GEX
CLASSIFICATION
Class II- 21 CFR8878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology
PREDICATE DEVICE
Fiber One (K100746) cleared June 11, 2010.
JUN 1 5 2012
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SECTION 7 510(K) SUMMARY [21 CFR 807.92]
DEVICE INFORMATION
Model Number 0010-2400 is supplied as a single-use, sterile product and is compatible with the GreenLight™ XPS Laser System. It can access the tissue in multiple planes. Model Number 0010-2400 is a liguid cooled delivery device which enables the delivery of up to 180W of power and aids in maintaining a clear environment at the fiber cap.
INTENDED USE
The Model Number 0010-2400 features a side firing mechanism delivering up to 180W of 532nm light to tissue. Model Number 0010-2400 can be used for the surgical incision/excision, vaporization, ablation, hemostasis and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue. muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands.
Model Number 0010-2400 will deliver 532nm laser energy from a compatible laser console (GreenLight XPS Laser System) to tissue during surgical procedures, including photoselective vaporization of the prostate for benign prostatic hyperplasia (BPH)
INDICATIONS FOR USE
Model Number 0010-2400 is a fiber optic delivery device intended for use with the GreenLight™XPS Laser System for its FDA cleared indications for use.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS TO THE PREDICATE DEVICE The Model Number 0010-2400 modification is deemed equivalent and there are no changes to the device intended use and/or device functional scientific technology.
| Model 0010-2400 | Fiber One | |
|---|---|---|
| 510(k) Number | K120870 | K100746 |
| Regulation Number | 21 CFR§878.4810 | 21 CFR§878.4810 |
| Regulation Name | Laser surgical instrument for usein general and plastic surgery andin dermatology | Laser surgical instrument for use ingeneral and plastic surgery and indermatology |
| Classification | Class II | Class II |
| Product Code | GEX | GEX |
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SECTION 7 510(K) SUMMARY [21 CFR 807.92]
| Model 0010-2400 | Fiber One | |
|---|---|---|
| Laser SystemCompatibility | GreenLight XPS Laser System | GreenLight XPS Laser System |
| Endoscope/CystoscopeCompatibility | 22 to 24 Fr continuous flow | 22 to 24 Fr continuous flow |
| Saline flow | ≥0.3mL/sec | ≥0.3mL/sec |
| Fiber and CapAssembly OuterDiameter | <2.3 mm | <2.3 mm |
| Total Length | 305cm | 305cm |
| Operation Length | 36cm | 36cm |
| Fiber Core Size | 750μm | 750μm |
| Internal Fiber Cooling | Yes | Yes |
| Max. Laser Power | 180W | 180W |
| Energy Limit | $650kJ$ | $400kJ$ |
| Beam Area at 2 mm | 0.48mm² | 0.48mm² |
| Power Density at2 mm | @ 180W = 326W/mm²@120W = 218W/mm² | @ 180W = 326W/mm²@120W = 218W/mm² |
| Materials | 304 stainless steel, polyamide,silica glass | 304 stainless steel, polyamide,silica glass |
| Sterilization | Ethylene Oxide | Ethylene Oxide |
| Dating* | 2 years, accelerated | 2 years, accelerated |
| Storage Conditions | 4 to 40 °C, keep dry | 4 to 40 °C, keep dry |
| Metal Cap* | Minor tolerance refinements toincrease process capability | Initial design |
| Labeling, IFU* | Clarifications to instructions, useand improved caution statements,2 additional languages added | Released at Rev B |
*denotes post-510k changes that did not trigger a new 510k submission.
SUMMARY OF NON-CLINICAL TESTING
All necessary bench testing was conducted on the Model Number 0010-2400 to support a determination of substantial equivalence to the predicate device.
SUBSTANTIAL EQUIVALENCE
The Model Number 0010-2400 uses the same surgical procedures and is targeted for the same patient population as the predicate device. The proposed indications for use for
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SECTION 7 510(K) SUMMARY [21 CFR 807:92]
Model Number 0010-2400 are equivalent to the indications for use/intended use, identical sterilization, and materials of the predicate device. There are no differences in the technological characteristics between the devices, nor does the change raise any new issues of safety or efficacy. Therefore, the Model Number 0010-2400 is substantially equivalent to the predicate device.
CONCLUSION
AMS considers Model Number 0010-2400 to be substantially equivalent to the Fiber One (K100746).
MANUFACTURING FACILITY
American Medical Systems 3070 Orchard Drive San Jose, CA 95134 Establishment Registration Number: 2937094
STERILIZATION FACILITY
Sterigenics US LLC 4900 Gifford Avenue Los Angeles, CA 90058 Establishment Registration Number: 2011171
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STERILIZATION
The modification to Model Number 0010-2400 did not affect sterilization. .
The following ETO residue values were extracted from the original 510k for Fiber One (MoXy) K100746, Appendix 3: Sterilization, page 12 of 15, Table 6.
| UNITNUMBER | SAMPLE ID | EO | ECH |
|---|---|---|---|
| 1 | Day 1, A | 2.10 | 1.10 |
| 2 | Day 1, B | 2.57 | 1.16 |
| 3 | Day 1, C | 2.16 | 1.47 |
| 4 | Day 2, A | 1.18 | 0.509 |
| 5 | Day 2, B | 1.32 | 0.201 |
| 6 | Day 2, C | 1.11 | 1.11 |
| 7 | Day 3, A | 0.702 | 1.05 |
| 8 | Day 3, B | 0.653 | 1.02 |
| 9 | Day 3, C | 0.571 | 0.807 |
| TABLE 6. Total Extracted Residues (mg/device) | ||||
|---|---|---|---|---|
| -- | -- | -- | -- | ------------------------------------------------ |
Model 0010-2400 is the same as Fiber One device and uses the same sterilization cycle and meets the ISO 10993-7:2008 recommendations for limited exposure values for EO <4 mg/device and ECH <9 mg/device.
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Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 1 5 2012
American Medical Systems % Ms. Doreen Nakamura Senior Regulatory Affairs Specialist 3070 Orchard Drive San Jose, California 95134
Re: K120870
Trade/Device Name: Model Number 0010-2400- for use with GreenLight XPS Laser System
Regulation Number: 21 CFR 878.4810
Regulation Name: Laser surgical instrument for use in general and plastic surgery and dermatology
Regulatory Class: II Product Code: GEX Dated: May 16, 2012 Received: May 17, 2012
Dear Ms. Nakamura:
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.
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Page 2 - Ms. Doreen Nakamura
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 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/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 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,
Fir. V.A. Nelson A.
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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AMERICAN MEDICAL SYSTEMS, INC.
MODEL NUMBER 0010-2400 SPECIAL 510(K)
SECTION 6
STATEMENT OF INDICATIONS FOR USE
510(k) Number: K120870
Device Name: Model Number 0010-2400
Indications for Use:
Model Number 0010-2400 is a fiber optic delivery device intended for use with the GreenLight™ XPS Laser System for its FDA cleared indications for use.
Prescription Use _ X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office af Devise Evaluation (ODE) ( moder
(Division Sign-Off) (Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number. K120870. 22
§ 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.