(83 days)
Not Found
No
The device description and intended use are purely mechanical and do not mention any computational or analytical capabilities. There is no mention of AI, ML, image processing, or data analysis.
No
The device is described as being used for tissue extraction during laparoscopic procedures, which is a diagnostic or surgical aid rather than a device for treating a disease or condition.
No
The device description and intended use indicate it is for tissue extraction during surgical procedures, not for diagnosis.
No
The device description explicitly states it consists of physical components: a polyurethane bag, a Nitinol wire, a polyethylene pusher, and a polyethylene sheath. This indicates it is a hardware device, not software-only.
Based on the provided information, the Rusch Memory Bag is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "tissue extraction during laparoscopic procedures." This describes a surgical tool used in vivo (within the body) to remove tissue.
- Device Description: The description details a physical bag, wire, pusher, and sheath designed for surgical use. There is no mention of reagents, calibrators, controls, or any components typically associated with testing biological samples in vitro (outside the body).
- Lack of IVD Characteristics: The document does not mention any of the key characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue samples after removal, etc.)
- Providing diagnostic information about a patient's health status
- Using reagents or analytical methods
In summary, the Rusch Memory Bag is a surgical device used for tissue removal during procedures, not a device used to perform tests on biological samples outside the body for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Rusch Memory Bag is intended to be used for tissue extraction during laparoscopic procedures including cholecystectomy, appendectomy, nephrectomy, laparoscopic colon surgery, thoracoscopy, lymphadenectomy, tubal pregnancy, intestinal hysterectomy and myomectomy.
Product codes
GCJ
Device Description
The Rusch Memory Bag will be offered in two (2) sizes -200ml bag with a 5cm opening for use with a 10mm trocar and an 800ml bag with a 10cm opening for use with a 10mm or 12mm trocar. The 10mm and 12mm application 800ml bags will each have separate and appropriately sized sheaths for insertion into the trocar. Each device consists of a polyurethane bag with a Nitinol wire, a polyethylene pusher and a polyethylene sheath.
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)
Reference Device(s)
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.
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013872 1/2
Image /page/0/Picture/2 description: The image contains the logo for "RUSCH. INTERNATIONAL Group Regulatory Affairs A Subsidiary of Teleflex Incorporated (USA)". The logo is in black and white. The word "RUSCH." is in a large, bold font, and the rest of the text is in a smaller font.
Tall Pines Park Jaffrey, NH 03452 (603) 532-7706 FAX (603) 532-8211 or 6108
:
510 (k) Summary
Submitter Name, Address, and Date of Submission: 1.
Rick Lykins Senior Requlatory Affairs Associate Rüsch International Tall Pines Park Jaffrey, NH 03452
(603) 532-7706 x 204 Telephone: (603) 532-6179 Fax: rlykins@tfx.com E-Mail:
Same as above Contact:
Name of the Device, Common, Proprietary (if known), and 2. Classification:
Classification Name: Laparoscope, General and Plastic Surgery Common Name: Extraction Baq
Proprietary Name: Rüsch Memory Bag
3. Identification of the legally marketed device to which the submitter claims equivalence:
The Rüsch Memory Bag is substantially equivalent in design and materials to:
1
Page 2/2 KO13872
4 . Description of the Device:
The Rusch Memory Bag will be offered in two (2) sizes -200ml bag with a 5cm opening for use with a 10mm trocar and an 800ml bag with a 10cm opening for use with a 10mm or 12mm trocar. The 10mm and 12mm application 800ml bags will each have separate and appropriately sized sheaths for insertion into the trocar. Each device consists of a polyurethane bag with a Nitinol wire, a polyethylene pusher and a polyethylene sheath.
5. Intended Use of the Device:
The Rusch Memory Bag is intended to be used for tissue extraction during laparoscopic procedures including cholecystectomy, appendectomy, nephrectomy, laparoscopic colon surgery, thoracoscopy, lymphadenectomy, tubal pregnancy, intestinal hysterectomy and myomectomy.
6. Summary of Technological Characteristics:
The Rüsch Memory Bag is identical in every way to the MTP Bag. The following technological Extraction characteristics are the same as or equivalent to the predicate Cook Urological LapSac:
Size Range (Rüsch Memory Baq 200ml and 800ml; Cook Urological LapSac 200ml and 750ml), Material (Rüsch Memory Baq Polyurethane and Cook Urological LapSac Nylon w/Polyurethane Coating), Introducer (An integral part of the Rüsch Memory Bag, an accessory with the Cook Urological LapSac)
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three overlapping lines that resemble an abstract human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 2 2002
Mr. Rick Lykins Senior Regulatory Affairs Associate Rusch International 50 Plantation Drive Tall Pines Park Jaffrey, New Hampshire 03452
Re: K013872
Trade Name: Rusch Memory Bag Regulation Number: 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: GCJ Dated: November 20, 2001 Received: November 21, 2001
Dear Mr. Lykins:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 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.
3
Page 2 - Mr. Rick Lykins
This letter will allow you to begin marketing your device as described in your Section 510(k) This lotter will and will you to ough finding of substantial equivalence of your device to a legally prematicated predicated. " 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of Compination at (301) 69 the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Ouvision 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,
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
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Page _1 of 1
K 013872 510(k) Number (if known):
Rüsch Memory Bag Device Name:
Indications for Use:
The Rusch Memory Bag is intended to be used for tissue during laparoscopic procedures includind extraction cholecystectomy, appendectomy, nephrectomy, laparoscopid colon surgery, thoracoscopy, lymphadenectomy, tubal pregnancy, hysterectomy and myomectomy.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Muriam C. Provost
ral, Restorative
510(k) Number K013872