(24 days)
Not Found
No
The summary describes a surgical instrument for coagulation and makes no mention of AI or ML technology.
No
The device is described as a surgical instrument for coagulation of soft tissue, indicating an invasive surgical function rather than a therapeutic one in the typical sense of alleviating symptoms or restoring function non-invasively or with less direct tissue alteration.
No
The device is described as a surgical instrument for coagulation of soft tissue, not for diagnosis.
No
The device description and intended use clearly indicate a physical surgical instrument ("Malleable Surgical Lightstic™ 180") used for coagulation of soft tissue. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the coagulation of soft tissue during surgical procedures. This is a therapeutic/surgical function performed directly on the patient's body.
- Device Description: It's described as a "Surgical Lightstic," indicating a surgical instrument.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) in vitro (outside the body) to provide diagnostic information. The device's function is to directly interact with tissue for therapeutic purposes.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Malleable Surgical Lightstic™ 180 is intended to be used as a surgical instrument for coagulation of soft tissue (including cardiac tissue) in conjunction with or without endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, cystoscopes, gastroscopes, colonoscopes), in the contact or non-contact mode in both open or closed surgical procedures (with or without handpiece). Its intended use is identical to the current Surgical Lightstic™ 180 (K011988)
Product codes
GEX, OCL
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue (including cardiac tissue)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
None required.
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.
0
DEC 2 0 2001
510(k) Summary
Malleable Surgical Lightstic™ 180
K1013001
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR §807 for the Malleable Surgical Lightstic™ 180.
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
| Joseph Curtis | |
|---|---|
| 10 Commerce Way | |
| Norton, MA 02766 | |
| Telephone: | (508) 285-1700 |
| Facsimile: | (508) 285-7579 |
| Contact Person: | same |
| Date Prepared: | June 22, 2001 |
Name of Device and Name/Address of Sponsor
Surgical Lightstic™ 180 CardioFocus, Inc. 10 Commerce Way Norton, MA 02766
Common or Usual Name
Laser Tissue Coagulator
Classification Name
Surgical Laser Instrument Accessories
Predicate Devices
The Malleable Surgical Lightstic 180 for use in cardiac tissue is identical to the current Surgical Lightstic 180 (K011988), and substantially equivalent for indications for use in cardiac tissue.
1
Intended Use
The Malleable Surgical Lightstic™ 180 is intended to be used as a surgical instrument for coagulation of soft tissue (including cardiac tissue) in conjunction with or without endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, cystoscopes, gastroscopes, colonoscopes), in the contact or non-contact mode in both open or closed surgical procedures (with or without handpiece). Its intended use is identical to the current Surgical Lightstic™ 180 (K011988)
Technological Characteristics and Substantial Equivalence
From a clinical perspective and comparing design specifications, the CardioFocus Malleable Surgical Lightstic " 180 and the CardioFocus predicate device are substantially equivalent and have the same intended use.
CardioFocus, Inc. believes the minor differences of the CardioFocus Malleable Surgical Lightstic" 180 and its predicate Surgical Lightstic™ 180 fiber laser accessories should not raise any concerns regarding the overall safety and effectiveness.
Performance Data
None required.
2
Image /page/2/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 movement or progress. The profiles are arranged in a row, with each one slightly overlapping the previous one. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
MAR 1 1 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
CardioFocus, Inc. c/o Mr. Joseph Curtis Vice President of Clinical and Regulatory Affairs 10 Commerce Way Norton, MA 02766
Re: K013901 Trade/DeviceName: Malleable Surgical Lightstic TM 1 80 Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II (two) Product Code: GEX, OCL Dated: November 21. 2001 Received: November 26, 2001
Dear Mr. Curtis:
This letter corrects our substantially equivalent letter of December 20, 2001.
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 (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 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.
3
Page 2 - Mr. Joseph Curtis
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 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.
This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
elmoe
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
KD13901 510(k) Number (if known):
Device Name:
Malleable Surgical Lightstic™ 180
Indications For Use:
Coagulation of Cardiac Tissue
These are identical indications to the already cleared indications for market Note: release in K011988.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hyt Plurdy
(Division Sign-Off)
Division of General, Restorative and Neurological Devices
510(k) Number K013901
OR Over-The-Counter Use
Prescription Use (Per 21 CFR §801.109)