(63 days)
Not Found
No
The description focuses on the mechanical function of a retrieval bag and does not mention any computational or analytical capabilities.
No
The device is described as a retrieval bag designed to contain and facilitate the removal of organs or stones during laparoscopic surgery, acting as a tool for surgical procedures rather than providing a therapeutic effect on the patient's condition.
No
The device description states it is a "single use retrieval bag designed to temporarily contain organs or stones and facilitate their removal from the patient," which indicates a therapeutic or surgical function rather than a diagnostic one.
No
The device description clearly describes a physical, hardware-based surgical instrument (a retrieval bag and tube) and does not mention any software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is designed to "temporarily contain organs or stones and facilitate their removal from the patient without contamination during laparoscopic surgery." This describes a surgical instrument used in vivo (within the living body) for specimen retrieval.
- Device Description: The description details a "laparoscopic instrument" with a "collapsible pouch" and a "long slender multi-part tube" for introduction through a trocar. This is consistent with a surgical device used during a procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the living body) to provide information about a physiological state, health, or disease. It doesn't involve testing samples like blood, urine, or tissue for diagnostic purposes.
Therefore, the LiNA-Bag is a surgical instrument, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
A single use retrieval bag designed to temporarily contain organs or stones and facilitate their removal from the patient without contamination during laparoscopic surgery such as the appendix, an ectopic pregnancy, gallbladder, gallstones, lymph nodes, ovaries, fibroid tumors, small sections of bowel and other tissue structures.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
The LiNA-Bag is a laparoscopic instrument consisting of a collapsible pouch attached and placed within a long slender multi-part tube allowing for introduction of said pouch through a laparoscopic trocar. Opening and closing of the pouch is activated by manual manipulation in a push and pull motion of the attached tube that has a corresponding nylon drawstring attached to the pouch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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).
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
APR 1 4 2003
510(K) Summary as required by 21 CFR section 807.92 for LiNA-BAG Prepared February 7, 2003
| Submitted by: | LiNA Medical CML ApS
Formervangen 5
Glostrup
Denmark DK-2600 |
|--------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person:
Device Trade Name:
Common Name:
Classification: | Mr. Niels Kornerup, President
LiNA-Bag
Laparoscopic Specimen Retrieval Device
Laparoscopic, General & Plastic Surgery, 876.1500 Class II |
| Predicate Devices: | Patton Endo-bag (K0122150), distributed by Patton Medical,
1000 Westbank Drive, Suite 5A200, Austin, TX 78746
ENDOPOUCH Specimen Retrieval Bag (K933104), manufactured by Ethicon,
Inc., P.O. Box 151, Somerville, NJ 08876
Auto Suture ENDO CATCH Single Use Specimen Pouch
(K922123), manufactured by U.S. Surgical, Division of TYCO, 150 Glover Ave.,
Norwalk, CT 06856 |
Description of Device:
The LiNA-Bag is a laparoscopic instrument consisting of a collapsible pouch attached and placed within a long slender multi-part tube allowing for introduction of said pouch through a laparoscopic trocar. Opening and closing of the pouch is activated by manual manipulation in a push and pull motion of the attached tube that has a corresponding nylon drawstring attached to the pouch.
Intended Use of Device:
The LiNA-Bag is a sterile, single-use bag designed to contain tissue, small organic matter temporarily in order to facilitate the removal of this matter without wound contamination during laparoscopic procedures.
Substantial Equivalence to Predicate Device:
The LiNA-Bag is substantially equivalent to the Patton Endo-bag (K0122150), distributed by Patton Medical, 1000 Westback Drive, Suite 5A200, Austin, TX 78746 and the ENDOPOUCH Specimen Retrieval Bag (K933104), manufactured by Ethicon, Inc., P.O. Box 151, Somerville, NJ 08876 and the Auto Suture ENDO CATCH Single Use Specimen Pouch (K922123), manufactured by U.S. Surgical, Division of TYCO, 150 Glover Ave, Norwalk, CT 06856.
1
Image /page/1/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, stacked on top of each other. The profiles are connected by a flowing, ribbon-like shape at the bottom. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 4 2003
Mr. Niels Kornerup President LiNa Medical CML ApS Formervangen 5 Glostrup, Denmark DK-2600
Re: K030422
Trade/Device Name: LiNa-Bag Regulation Number: 21 CFR 876.1500 Regulation Names: Endoscope and accessories Regulatory Class: II Product Codes: GCJ Dated: February 7, 2003 Received: February 10, 2003
Dear Mr. Kornerup:
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. Iisting 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.
2
Page 2 - Mr. Niels Kornerup
This letter will allow you to begin 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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained from the Division of Small Manufacturers, International 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.
Sincerely yours,
Mark N Millkern
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
3
NR. 999 S. 3
Indications for Use
13.5 - Found sures I ruy 1 diministration ar Jos Destens and Radiological Health
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Side I af 2
510(k) Number (if known): K030422
LiNA-Bag, model LB-60 & LB-100 Device Name:
Indications for Use:
A single use retrieval bag designed to temporarily contain organs or stones and facilitate their removal from the patient without contamination during laparoscopic surgery such as the appendix, an ectopic pregnancy, gallbladder, gallstones, lymph nodes, ovaries, fibroid tumors, small sections of bowel and other tissue structures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark R. Milleson
(Division Sign-Off)
Restorative Divis anc
510(k) Number K030926
http://www.fda.gov/cdrh/ode/indicate.html
21-03-03