(97 days)
No
The document describes a passive laser delivery fiber and does not mention any computational or analytical capabilities that would involve AI/ML.
Yes
The device is described as a laser delivery device for various surgical applications, including incision, vaporization, ablation, and coagulation of soft tissue, which are all therapeutic actions.
No
Explanation: The device is described as a laser delivery system used for surgical applications like incision, vaporization, ablation, and coagulation of tissue. Its intended uses are therapeutic, not diagnostic.
No
The device description clearly states it is a physical fiber optic cable made of silica quartz glass, intended for delivering laser energy, and connects to a laser system via an SMA 905 connector. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description and intended use of the Adler MicroMed Laser Surgery Fibers clearly state that they are used for surgical applications involving the direct interaction with and manipulation of soft tissue within the body. This includes incision, vaporization, ablation, hemostasis, and coagulation.
- Lack of Sample Analysis: There is no mention of the device being used to analyze samples taken from the body. Its function is to deliver laser energy directly to tissue.
Therefore, the device falls under the category of a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Fibers are indicated for use in general surgical applications for incision, vaporization, ablation, hemostasis or coagulation of soft tissue. It is also indicated for use in open or closed endoscopic applications including excision,tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors or lesions, tissue vaporization, hemostasis and or coagulation may be indicated.
The Adler MicroMed Laser Surgery Fibers have a wavelength range of 450 nm to 2100 nm, can be used in contact and non-contact mode and are indicated for use in general surgery, urology, gastroenterology, gynecology, gynecology, drmnology, vascular surgery, neurosurgery, plastic surgery, ENT and endovenous occlusion of the greater saphenous veni in the patient with superficial vein reflux and laser assisted lipolysis with a cleared compatible laser marketed for the mononed intended uses and using an SMA 905 connector.
The Fibers are indicated for use in general surgical applications for incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue. It is also indicated for use in open or closed endoscopic applications where incision, excision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors or lesions, tissue vaporization, hemostasis and or coagulation may be indicated.
The Adler MicroMed Laser Surgery Fibers have a wavelength range of 450 nm to 2100 mm, can be used in contact and non-contact mode and are indicated for use in general surgery, urology, gastroenterology, gynecology, dermatology, vascular surgery, neurosurgery, plastic surgery, ENT and endovenous occlusion of the greater saphenous vein in the patient with superficial vein reflux and laser assisted lipolysis with a cleared compatible laser marketed for the mentioned intended uses and using an SMA 905 connector.
Product codes
GEX
Device Description
The Adler MicroMed Laser Surgery Fibers are single use laser delivery devices provided sterile and intended for medical applications in various fields of laser surgerv.
The devices are based on a silica quartz glass core, have a length range of 6.5 feet (2 meters) to 9.8 feet (3 meters) and a wavelength range between 450 and 2100nm. The proximal end of the fibers is connected to a cleared laser system via an SMA 905 connector, while the distal end delivers the laser energy to the target tissue inn pulsed and continuous wave mode.
The distal end may have a rounded or conical silica cap, or non-capped tips, which may be flat, spherical, ball, conical or bended for the various intended uses and effects.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, internal organs, tumors, lesions, greater saphenous vein
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
Non clinical Performance Data:
The following performance tests has been conducted in order to demonstrate that the Adler Laser Surgery Fibers are as safe and as effective as the cleared predicate devices:
Sterilization: Sterilization Validation, SAL Evaluation, EO Validation
Packaging: Packaging Validation, Package Integrity, Package Sealing Validation
Shelf Life: Shelf Life Validation
Biocompatibility: Biocompatibility testing relevant to products
Functional: Aging test, Energy transmission validation
Clinical Performance data: None
Key Metrics
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/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines suggesting hair or fabric. The profiles are arranged in a way that they appear to be connected. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Adler MicroMed Incorporated Mr. Brian Chandler Chief Executive Officer 6842 Elaine Way San Diego, California 92120
December 1, 2015
Re: K152417 Trade/Device Name: Adler MicroMed Laser Surgery 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: September 10, 2015 Received: September 10, 2015
Dear Mr. Chandler:
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 [SELECT ONE: Part 801 [or, for IVDs only] Parts 801 and 809]); medical device reporting of medical device-related adverse events) (21 CFR
1
803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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 yours,
Joshua C. Nipper -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S.
For Director
Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K152417
Device Name
Adler MicroMed Laser Surgery Fibers
Indications for Use (Describe)
The Fibers are indicated for use in general surgical applications for incision, vaporization, ablation, hemostasis or coagulation of soft tissue. It is also indicated for use in open or closed endoscopic applications including excision,tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors or lesions, tissue vaporization, hemostasis and or coagulation may be indicated.
The Adler MicroMed Laser Surgery Fibers have a wavelength range of 450 nm to 2100 nm, can be used in contact and non-contact mode and are indicated for use in general surgery, urology, gastroenterology, gynecology, gynecology, drmnology, vascular surgery, neurosurgery, plastic surgery, ENT and endovenous occlusion of the greater saphenous veni in the patient with superficial vein reflux and laser assisted lipolysis with a cleared compatible laser marketed for the mononed intended uses and using an SMA 905 connector.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
2 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 logo for Adler MicroMed. The logo consists of three blue curved lines above the text "ADLER MicroMed." The word "ADLER" is in gray, while "MicroMed" is in blue. There is a trademark symbol to the right of "Med."
510(k) SUMMARY
| Title: | Adler MicroMed Surgical Laser Fibers |
|---|---|
| Submitter: | Adler MicroMed, Inc., |
| 6842 Elaine Way San Diego | |
| California 92120 | |
| USA | |
| Contact: | Brian Chandler |
| Tittle : | CEO |
| Phone : | 484-995-7919 |
| E-Mail: | bchandler@adlermicromed.com |
| Address: | 6842 Elaine Way San Diego |
| California | 92120 |
| USA | |
| Date | |
| Prepared: | July 12, 2015 |
| Device Trade | |
| Name: | Adler MicroMed Surgical Laser Fibers |
| Common | |
| Name: | Fiber Optic laser delivery system |
| Classification | |
| Name: | Laser surgical instrument for use in general and plastic surgery and in |
| dermatology | |
| Device product code: | GEX |
| Device | |
| Classification | 21 CFR 878.4810 |
| Predicate | |
| Device: | Oberon Laser Surgery Fiber, K140470 |
Device Description:
The Adler MicroMed Laser Surgery Fibers are single use laser delivery devices provided sterile and intended for medical applications in various fields of laser surgerv.
The devices are based on a silica quartz glass core, have a length range of 6.5 feet (2 meters) to 9.8 feet (3 meters) and a wavelength range between 450 and 2100nm. The proximal end of the fibers is connected to a cleared laser system via an SMA 905 connector, while the distal end delivers the laser energy to the target tissue inn pulsed and continuous wave mode.
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Image /page/4/Picture/0 description: The image shows the logo for Adler MicroMed. The word "ADLER" is in gray, and the word "MicroMed" is in blue. There are three blue curved lines above the word "ADLER".
K152417 Page 2 of 2
The distal end may have a rounded or conical silica cap, or non-capped tips, which may be flat, spherical, ball, conical or bended for the various intended uses and effects.
Intended Use:
The Fibers are indicated for use in general surgical applications for incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue. It is also indicated for use in open or closed endoscopic applications where incision, excision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors or lesions, tissue vaporization, hemostasis and or coagulation may be indicated.
The Adler MicroMed Laser Surgery Fibers have a wavelength range of 450 nm to 2100 mm, can be used in contact and non-contact mode and are indicated for use in general surgery, urology, gastroenterology, gynecology, dermatology, vascular surgery, neurosurgery, plastic surgery, ENT and endovenous occlusion of the greater saphenous vein in the patient with superficial vein reflux and laser assisted lipolysis with a cleared compatible laser marketed for the mentioned intended uses and using an SMA 905 connector.
Substantial Equivalence:
The Adler MicroMed Laser Surgery Fibers have the same mechanism of action, same intended use and the same technological characteristics as the predicate devices, the Oberon Laser Surgery Fibers, (K140470).
Non clinical Performance Data :
The following performance tests has been conducted in order to demonstrate that the Adler Laser Surgery Fibers are as safe and as effective as the cleared predicate devices:
| Sterilization | Sterilization Validation
SAL Evaluation
EO Validation |
|------------------|-------------------------------------------------------------------------|
| Packaging | Packaging Validation
Package Integrity
Package Sealing Validation |
| Shelf Life | Shelf Life Validation |
| Biocompatibility | Biocompatibility testing relevant to products |
| Functional | Aging test, Energy transmission validation |
Clinical Performance data: None
Conclusion:
Based on above, we conclude that equivalence has been demostrated and that Adler MicroMed Laser Surgery Fibers are as safe and effective as the predicate device.