(30 days)
Dornier's Medilas H RFID Laser Fibers are intended to be used as an accessory for the Dornier Medilas H Holmium Laser ("Laser"). This laser is intended for cutting, vaporization, ablation, and coaqulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, and colonoscopes), or for open surgery for contact or non-contact surgery with or without a handpiece for use in incision/excision, vaporization, ablation and coagulation of soft tissue. The Laser is indicated for use in medicine and surgery, in the following medical specialties:
Arthroscopy, Urology, Lithotripsy, Pulmonology, Gastroenterology, Gynecology, ENT, General Surgery
The Medilas H RFID Laser Fiber is a modification to Dornier's currently cleared Dornier Medilas H Laser Fiber K022544.
The provided text, K121938, describes Dornier's Medilas H RFID Laser Fibers, which is a modification of an already cleared device. This submission is a Special 510(k) notice, indicating that the device has the same intended use and similar indications, principles of operation, and technological characteristics as its predicate devices, with only minor differences that do not raise new questions of safety or effectiveness.
Therefore, the submission primarily focuses on demonstrating that the modified device performs as safely and effectively as the predicate devices. This type of submission does not typically involve the extensive clinical studies with human subjects, ground truth establishment, or multi-reader, multi-case studies that would be associated with entirely new medical devices or software algorithms.
Based on the provided document, here is the information requested, with "N/A" for criteria not addressed in this type of submission:
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states that "Performance data demonstrates that the Dornier Medilas H RFID Laser Fibers are as safe and effective as the listed predicates." Specific quantitative acceptance criteria and detailed performance metrics are not typically required or presented in this type of 510(k) summary for accessory modifications. The "performance data" likely refers to bench testing to ensure the fiber's physical and functional properties (e.g., power transmission, durability, RFID functionality) are comparable to the predicate.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety equivalent to predicate devices | Performance data demonstrates safety equivalent to predicate devices. |
| Effectiveness equivalent to predicate devices | Performance data demonstrates effectiveness equivalent to predicate devices. |
| RFID functionality (implied) | The RFID functionality, as a new feature, would have been tested to ensure it operates as intended (e.g., communication with the laser system), but specific metrics are not detailed in this summary. |
| Physical and functional equivalence to predicate laser fibers (implied) | Likely demonstrated through bench testing, but specific metrics are not detailed in this summary. |
2. Sample size used for the test set and the data provenance: N/A (No human subject test set is described for this type of submission.)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (Ground truth established by experts is not applicable to this type of device modification submission.)
4. Adjudication method for the test set: N/A (No human subject test set or adjudication process is described.)
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: N/A (This is not an AI device, and no MRMC study was conducted.)
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: N/A (This is a physical medical device accessory, not an algorithm.)
7. The type of ground truth used: N/A (Not applicable. The equivalence is based on engineering design, bench testing, and comparison to existing predicate devices, not clinical ground truth in the context of diagnostic accuracy.)
8. The sample size for the training set: N/A (Not applicable, as this is a physical device accessory, not a machine learning algorithm.)
9. How the ground truth for the training set was established: N/A (Not applicable.)
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510(k) SUMMARY
Dornier's Medilas H Laser Fibers
1 2012 AUG
Submitter's Name. Address, Telephone Number, Contact Person and Date Prepared
Dornier MedTech America 1155 Roberts Blvd. Kennesaw, GA 30144
Phone: 770-514-6163 Fax: 770-514-6291 Date Prepared: June 28, 2012
Contact Person: John Hoffer
Phone: 770-514-6163
Name of Device and Name/Address of Sponsor
Medilas H RFID Laser Fibers 1155 Roberts Blvd. Kennesaw, GA 30144
Common or Usual Name
Holmium Laser Fibers
Classification Name
Laser Instrument, (Accessory); Product Code GEX
Predicate Devices
Dornier Medilas H Laser Fiber K022544 Accuflex Laser Fibers K050108 Lumenis SlimLine Fibers K011703
Purpose of the Special 510(k) notice.
The Medilas H RFID Laser Fiber is a modification to Dornier's currently cleared Dornier Medilas H Laser Fiber K022544.
Intended Use
Dornier's Medilas H RFID Laser Fibers are intended to be used as an accessory for the Dornier Medilas H Holmium Laser ("Laser"). This laser is intended for cutting, vaporization, ablation, and coaqulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, and colonoscopes), or for open surgery for contact or non-contact surgery with or without a handpiece for use in incision/excision, vaporization, ablation and coagulation of soft tissue. The Laser is indicated for use in medicine and surgery, in the following medical specialties:
Arthroscopy, Urology, Lithotripsy, Pulmonology, Gastroenterology, Gynecology, ENT, General Surgery
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Substantial Equivalence
Dornier's Medilas H RFID Laser Fibers has the same intended use and similar indications, principles of operation, and technological characteristics as the predicate devices. The minor differences in the technological characteristics do not raise any new questions of safety or effectiveness. Performance data demonstrates that the Dornier Medilas H RFID Laser Fibers are as safe and effective as the listed predicates. Thus, the Dornier Medilas H RFID Laser Fibers are substantially equivalent to its predicate devices.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the bird.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
AUG 1 2012
Dornier Medtech America, Incorporated % Mr. John Hoffer 1155 Roberts Boulevard Kennesaw, Georgia 30144
Re: K121938
Trade/Device Name: Dornier Medilas H RFID Laser Fibers 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: June 28, 2012 Received: July 02, 2012
Dear Mr. Hoffer:
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
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Page 2 - Mr. John Hoffer
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/ReportalProblem/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.
Rar
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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Indications for Use Statement
510(k) Number (if known): K12
Device Name: Dornier Medilas H RFID Laser Fibers
Indications for Use:
Dornier's Medilas H RFID Laser Fibers are intended to be used as an accessory for the Dornier Medilas H Holmium Laser ("Laser"). This laser is intended for cutting, vaporization, and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, and colonoscopes), or for open surgery for contact or non-contact surgery with or without a handpiece for use in incision/excision, vaporization, ablation and coagulation of soft tissue. The Laser is indicated for use in medicine and surgery, in the following medical specialties:
Arthroscopy Urology Lithotripsy Pulmonology Gastroenterology Gynecology ENT General Surgery
Prescription Use
(Per 21 C.F.R. 801.109)
AND/OR
Over-The-Counter Use_ (Per 21 C.F.R. 807 Subpart C) Mille R.
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number 121
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE 'OK' ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 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.