(265 days)
No
The description focuses on the laser technology for skin perforation and does not mention any AI or ML components. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is used for skin perforation to draw capillary blood for screening purposes, not for treating a disease or condition.
No
The device is used to obtain capillary blood samples for subsequent analysis, but it does not perform the analysis itself. Therefore, it is not a diagnostic device.
No
The device description explicitly states it is a "pulsed erbium doped yittrium-aluminumgamet (Er: YAG) laser" and outputs a "single pulse of laser light," indicating it is a hardware device that physically interacts with the skin.
Based on the provided information, the LightLance™ Laser Skin Perforator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body in vitro (outside the body) to provide information for diagnostic, monitoring, or compatibility purposes. Examples include blood glucose meters, pregnancy tests, and laboratory analyzers.
- The LightLance™ Laser Skin Perforator's intended use is to obtain a capillary blood sample by perforating the skin. It is a tool for sample collection, not for analyzing the sample itself.
- The description explicitly states its purpose is "for the perforation of skin to draw capillary blood for screening purposes" and "for obtaining capillary blood samples for subsequent analysis." This clearly indicates it's a pre-analytical device, facilitating the collection of a sample that will then be analyzed by a separate device (like a blood glucose meter).
Therefore, the LightLance™ Laser Skin Perforator is a medical device used for sample collection, but it does not perform the in vitro diagnostic analysis itself.
N/A
Intended Use / Indications for Use
The LightLance™ Laser Skin Perforator is intended to be used for ablation of skin tissue to establish capillary blood access. The LightLance™ Laser Skin Perforator general indication for use is for the perforation of skin to draw capillary blood for screening purposes. The device is specifically indicated for obtaining capillary blood samples for subsequent analysis of blood glucose concentration in both institutional and home settings.
Product codes
GEX
Device Description
The LightLance™ Laser Skin Perforator is a pulsed erbium doped yittrium-aluminum-gamet (Er: YAG) laser. It outputs a single pulse of laser light with a wavelength of 2940 nm, which ablates a small hole in the skin to a depth sufficient to access capillary blood.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Institutional and home settings
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)
The LightLance™ Laser Skin Perforator has been thoroughly tested according to international standards equivalent to the standard IEC 601. Results from the testing indicate that the device is as safe and effective as the predicate device.
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
MAY 3 0 2002
K013021 1/3
Attachment 11
510(k) Summary
LightLance™ Laser Skin Perforator
Submitted by:
Innotech USA, Inc. Laser Devices Division 2975 Westchester Avenue, Suite 401 Purchase, NY 10577
September 4, 2001
This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
Contact Person:
Howard M. Holstein, Partner Hogan & Hartson L.L.P. Columbia Square 555 Thirteenth Street, NW Washington, DC 20004-1109 Phone: (202) 637-5813 Telefax: (202) 637-5910 E-mail: HMHOLSTEIN@HHLAW.COM
510(k) for the LightLance™ Laser Skin Perforator
0001400
1
KO13021 2/3
2. Device Name and Classification:
| Trade Name: | LightLance™ Laser Skin Perforator |
|---|---|
| Classification Name: | Laser instrument, surgical, powered |
| Common Name: | Laser Skin Perforator |
| Classification Panel: | General and Plastic Surgery: Panel 79 |
| CFR Section: | 21 CFR §878.4810 |
| Device Class: | Class II |
Substantial Equivalence: 3.
The LightLance™ Laser Skin Perforator substantially equivalent to the current, legally marketed LASETTE™ (K983673) and (K981746). The LightLance™ Laser Skin Perforator has the same intended use and general and specific indications as both of predicated Lasette devices. These devices have very similar principles of operation and technological characteristics. The minor technological differences do not raise any new questions of safety and effectiveness. Performance data demonstrates that LightLance™ is as safe and effective as the Lasette.
Device Description: 4.
The LightLance™ Laser Skin Perforator is a pulsed erbium doped yittrium-aluminumgamet (Er: YAG) laser. It outputs a single pulse of laser light with a wavelength of 2940 nm, which ablates a small hole in the skin to a depth sufficient to access capillary blood.
510(k) for the LightLance™ Laser Skin Perforator
000161
2
01304 3/3
5. Intended Use/Indications for Use:
The LightLance™ Laser Skin Perforator is intended to be used for ablation of skin tissue to establish capillary blood access, The LightLance™ Laser Skin Perforator general indication for use is for the perforation of skin to draw capillary blood for screening purposes. The device is specifically indicated for obtaining capillary blood samples for subsequent analysis of blood glucose concentration in both institutional and home settings.
Performance Data: 6.
The LightLance™ Laser Skin Perforator has been thoroughly tested according to international standards equivalent to the standard IEC 601. Results from the testing indicate that the device is as safe and effective as the predicate device.
Conclusion: 7.
The LightLance™ Laser Skin Perforator is substantially equivalent to the current legally marketed Cell Robotics Lasette (K983673, K981746).
510(k) for the LightLance™ Laser Skin Perforator
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Innotech USA, Inc. c/o Mr. Howard Holstein Hogan and Hartson L.L.P. 555 Thirteenth Street, NW Washington, D.C. 20004-1109
Re: K013021
Trade/Device Name: LightLance™ Laser Skin Perforator Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: February 22, 2002 Received: March 5, 2002
Dear Mr. Holstein:
We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for two based in the 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 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.
4
Page 2 - Mr. Howard Holstein
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin marketing your device of your device to a legally prematket notification. The PDA intellig of successification 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 and If you desire specific advice for your devices di success, please contact the Office of additionally 21 CFC For 807.10 for in Title undersons on the promotion and advertising of Compliance at (301) 594-4637. Thumbilany for quest (301) 594-4639. Also, please note the your device, picase comace the Office of remarket notification" (21 CFR Part 807.97). regulation entitled, "Misbranding by reference to premarket notifical from the Other general information on your responsibilities under the Act may be obtained from the Other general information on your responsiver and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INNOTECH US A. II
INDICATION FOR USE STATEMENT
| 510(k) Number: | New Submission K013021 |
|---|---|
| ---------------- | ------------------------- |
LightLance™ Laser Skin Perforator Device Name:
Indication for Use:
The LightLance™ Laser Skin Perforator is intended to be used for ablation of skin tissue to establish capillary blood access. The LightLance™ Laser Skin Perforator general indication for use is for the perforation of skin to draw capillary blood for screening purposes. The device is specifically indicated for obtaining capillary blood samples for subsequent analysis of blood glucose concentration in both institutional and home settings
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
Prescription Use
510(k) Number K013021
OR Over-the-Counter Use
(per 21 CFR 801.109)
000008
INNOTECH USA, INC., 2975 WESTCHESTER AVENUE, SUITE 401, PURCHASE NY 10577 E-MAIL: innotec@ix.netcom.com TELEPHONE: (914) 251-0700 FAX: (914) 251-0951