(79 days)
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No
The provided text describes a mechanical device (flexible sheath) for protecting surgical scopes and delivering irrigation during laser procedures. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities.
No.
The device is described as a protective sheath for the working channel of a flexible scope, and provides irrigation during laser procedures; it does not directly treat a disease or condition.
No
Explanation: The device is described as a protective sheath used during surgical procedures involving lasers to prevent damage to the working channel of scopes and provide irrigation. Its function is interventional/surgical, not diagnostic.
No
The device description clearly outlines physical components (flexible sheaths, fiber clamp/Yee piece) and their intended use in surgical procedures involving physical interaction with other medical devices (flexible scopes, laser fibers). This indicates a hardware-based medical device, not a software-only one.
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.
- Device Function: The FlexGuard Family of sheaths is described as a device used during surgical procedures to protect the working channel of a scope and provide irrigation. It is used in vivo (within the body) during surgery, not in vitro (outside the body) on a sample.
- Intended Use: The intended use clearly states its purpose in surgical procedures for incision, ablation, vaporization, and coagulation of soft tissue. This is a therapeutic/surgical function, not a diagnostic one performed on a sample.
Therefore, the FlexGuard Family of sheaths falls under the category of a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The FlexGuard Family of sheath's are intended for use in surgical procedures using flexible scopes and other approved flexible or rigid fiber optic delivery devices, to protect the working channel from damage when a laser fiber is introduced and also to provide irrigation to the surgical site when used for incision, ablation, vaporization and coagulation of soft tissue with any approved laser with a wavelength from 532nm to 2100nm in medical specialties including: Urology, Gastroenterology, Thoracic, Head and Neck, Pulmonary, Gynecology, ENT and General Surgery
Product codes
GEX, FED
Device Description
The FlexGuard is a family of flexible sheaths that are used to protect the working channel of a flexible scope or surgical device from mechanical damage when the laser fiber is introduced into the working channel. The tip of the FlexGuard is allowed to protrude approx 3mm beyond the laser fiber, this assembly is then inserted into the working channel of the scope. The FlexGuard Family is designed to work with a range of laser fibers from 200 micron to 600 micron diameter. It consists of: Flexible Sheath Fiber clamp/Yee piece
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Urology, Gastroenterology, Thoracic, Head and Neck, Pulmonary, Gynecology, ENT and General Surgery
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
0
Attachment V
JUN 2 1 2007
510(k) Summary
1.General Information
Submitter:
AllMed Systems Inc. 9232 Klemetson Drive Pleasanton CA 94588
Phone: 925-468-0433
Fax 925-399-5984
Contact Person Peter Allen
Date Prepared 4th April 2007
2. Names
| Device Name | FlexGuard Family |
|---|---|
| Classification Name | Laser Accessory |
3. Predicate Device
Cook - Laser Ureteral Catheter
4. Product Description
The FlexGuard is a family of flexible sheaths that are used to protect the working channel of a flexible scope or surgical device from mechanical damage when the laser fiber is introduced into the working channel. The tip of the FlexGuard is allowed to protrude approx 3mm beyond the laser fiber, this assembly is then inserted into the working channel of the scope. The FlexGuard Family is designed to work with a range of laser fibers from 200 micron to 600 micron diameter.
It consists of:
1
Flexible Sheath Fiber clamp/Yee piece
Reference Attachment II for photographs detailing and describing the Reference Attachments of the FlexGuard. Reference Appendix VIII for a list of fibers that can be used in conjunction with the FlexGuard
2
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AllMed Systems, Inc. % Mr. Peter Allen President 9232 Klemetson Drive Pleasanton, California 94588
JUN 2 1 2007
Re: K070924
Trade/Device Name: FlexGuard 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, FED
Dated: May 4, 2007 Received: May 7, 2007
Dear Mr. Allen:
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
3
Page 2 -- Mr. Peter Allen
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (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) This letter will anow you to ogin maining of substantial equivalence of your device to a legally premarket notheation: "The PDA miams of casification 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 If you desire specific acrivaliance at (240) 276-0115. Also, please note the regulation entitled, Coniact the Office of Compilance in (21CFR Part 807.97). You may obtain Whisolanding of Nierence to promotion on your the Act from the Division of Small other general information on Jour response Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Octress http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Malkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number: K070924
FlexGuard Device Name:
Indications For Use:
The FlexGuard Family of sheath's are intended for use in surgical procedures using flexible scopes and other approved flexible or rigid fiber optic delivery devices, to protect the working channel from damage when a laser fiber is introduced and also to provide irrigation to the surgical site when used for incision, ablation, vaporization and coagulation of soft tissue with any approved laser with a wavelength from 532nm to 2100nm in medical specialties including: Urology, Gasteroenterology, Thoracic, Head and Neck, Pulmonary, Gynecology, ENT and General Surgery
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
62.4
Number 167095
510(k) Number-
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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