(139 days)
Not Found
No
The device description and performance studies focus on mechanical function and reprocessing validation, with no mention of AI or ML.
No.
The device is used to remove polyps and obtain tissue specimens for examination, which is a diagnostic rather than a therapeutic function.
Yes
The device is used to "obtain a specimen of tissue for microscopic examination," which is a step in the diagnostic process.
No
The device description clearly outlines physical components like forceps, handles, jaws, and a plastic sheath, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes. This examination is performed outside of the body (in vitro).
- Device Function: The MediSISS Reprocessed Non-electric Biopsy Forceps are used to obtain a specimen of tissue from the body. While the tissue specimen will be used for microscopic examination (which is an in vitro diagnostic process), the forceps themselves are the tool for collecting the sample, not for performing the diagnostic test on the sample.
- Intended Use: The intended use clearly states "to remove polyps, and obtain a specimen of tissue for microscopic examination." This describes a surgical/procedural function, not an in vitro diagnostic test.
The device is a surgical instrument used to collect a sample that will then be used in an IVD process (microscopic examination). The forceps themselves are not performing the diagnostic test.
N/A
Intended Use / Indications for Use
MediSISS Reprocessed Non-electric GI Biopsy Forceps are to be used during minimally invasive endoscopic procedures to remove polyps and obtain tissue samples for microscopic examination.
The MediSISS Reprocessed Non-electric Biopsy Forceps are intended to be used to remove polyps, and obtain a specimen of tissue for microscopic examination.
Product codes (comma separated list FDA assigned to the subject device)
NON, 78 NON
Device Description
MediSISS Reprocessed Non-electric GI Biopsy Forceps are designed for endoscopic use to retrieve tissue samples for microscopic inspection. Forceps outer diameters range from 2.2mm to 2.5mm and working lengths vary from 160cm. A syringe-like proximal handle opens and closes the distal instrument jaws, that are available in multiple design configurations such as Oval, Alligator, Smooth, or Fenestrated with and without a needle. The working length of the biopsy forceps is coated with a plastic sheath to decrease friction.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
GI
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)
MediSISS has validated its cleaning, sterilization, functional performance and packaging and distribution processed Non-Electric GI Biopsy Forceps. Successful validation, and routine tests monitor the safety and effectiveness of our product post sterilization. We have demonstrated with a high degree of assurance that MediSISS Reprocessed Non-Electric GI Biopsy Forceps are substantially equivalent to the new and unused predicate devices, and will continue to be safe and effective for the maximum number of intended uses.
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
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments 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 (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. 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 § 876.9.
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Image /page/0/Picture/0 description: The image shows the logo for MediSISS, a surgical instrument service and sterilization company. The logo features the company name in a stylized font, with the letters "MediSISS" in bold, black letters. Above the company name is the trademark symbol. Below the company name is the text "Surgical Instrument Service & Sterilization".
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
Submitted by: MediSISS 2747 SW 6th St. Redmond, OR 97756 Telephone: (541) 923-3310 Facsimile: (541) 923-3375 Email: bijames(@medisiss.com September 27, 2004
FEB 1 4 2005
Contact Person Brandi James Proprietary Name MediSISS Reprocessed Non-electric GI Biopsy Forceps Common Name Reprocessed Cold GI Biopsy Forceps Classification Gastroenterology/Urology Forceps, Biopsy, Reprocessed, per 21 CFR 876.1075, Product Code: NON, Regulatory Class II.
Device Description and Technological Characteristics:
MediSISS Reprocessed Non-electric GI Biopsy Forceps are designed for endoscopic use to retrieve tissue samples for microscopic inspection. Forceps outer diameters range from 2,2mm to 2.5mm and working lengths vary from 160cm. A syringe-like proximal handle opens and closes the distal instrument jaws, that are available in multiple design configurations such as Oval, Alligator, Smooth, or Fenestrated with and without a needle. The working length of the biopsy forceps is coated with a plastic sheath to decrease friction.
Predicate Device 510(k)s
Identification of legally marketed predicate device Original Equipment Manufacturer's 510(k)s:
| Manufacturer | 510(k)# |
|---|---|
| Bard | K912549 |
| Esco Precision, Inc. | K900015 |
| Olympus | K955065 |
Summary of Validation Data: MediSISS has validated its cleaning, sterilization, functional performance and packaging and distribution processed Non-Electric GI Biopsy Forceps. Successful validation, and routine tests monitor the safety and effectiveness of our product post sterilization. We have demonstrated with a high degree of assurance that MediSISS Reprocessed Non-Electric GI Biopsy Forceps are substantially equivalent to the new and unused predicate devices, and will continue to be safe and effective for the maximum number of intended uses.
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Image /page/1/Picture/0 description: The image shows the logo for MediSISS, a surgical instrument service and sterilization company. The logo features the company name in a stylized font, with the letters "MediSISS" in bold, black letters. Above the company name is a trademark symbol. Below the company name is the text "Surgical Instrument Service & Sterilization".
Standards
MediSISS Reprocessed Non-Electric GI Biopsy Forceps are either tested and/or processed in conformance with the applicable parts of the following standards:
- ANSVAAMI/ISO 11737-1-1995: Sterilization of Medical Devices-Microbiological Methods-. Part 1: Estimation of population of microorganisms on products.
- AAMI TIR No. 12-1994-Designing, Testing, and Labeling Reusable Medical Devices for t Reprocessing in Health Care Facilities: A Guide for Device Manufacturers.
- ASTM D4164: 2001 DC 13, AL 1: Performance Testing of Shipping Containers and Systems. .
- ISO 11607: 2003-Packaging for terminally sterilized medical devices. ●
- ANSI/AAMI/ISO 11135:1994, Medical devices--- Validation and routine control of ethylene oxide . sterilization.
- ANSI/AAMI/ISO 10993:1995, Biological Evaluation-Part 7: Ethylene Oxide Sterilization . Residuals.
- . ASTM F88-Seal strength of Flexible Barrier Materials.
- ASTM F1980: 2002—Standard Guide for Accelerated Aging of Sterile Medical Device Packages .
- United States Pharmacopeia 24-Sterility Test �
- ASTM F2096-02 Standard Test Method for Detecting Gross Leaks in Porous Medical Packaging ● by Internal Pressurization (Bubble Test).
Intended Use
MediSISS Reprocessed Non-electric GI Biopsy Forceps are to be used during minimally invasive endoscopic procedures to remove polyps and obtain tissue samples for microscopic examination.
Contraindications
The MediSISS Reprocessed Non-electric GI Biopsy Forceps should not be used when GI endoscopic procedures are contraindicated.
Conclusion
MediSISS Reprocessed Non-electric GI Biopsy Forceps are substantially equivalent to the legally marketed predicate devices with respect to cleanliness, sterility, design, packaging and intended use.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 4 2005
Ms. Brandi James Regulatory Specialist MediSISS 2747 SW 6th Street REDMOND OR 97756
K042659 Re: Trade/Device Name: MediSISS Reprocessed Non-Electrical GI Biopsy Forceps (SEE ENCLOSURE) Regulation Number: 21 CFR §876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: I Product Code: 78 NON Dated: December 23, 2004 Received: December 27, 2004
Dear Ms. James:
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 (Premarket Approval), 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
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 one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/dsmadsmam.html
Sincerely yours,
Nancy C. brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the word "MediSISS" in a stylized font. The word is surrounded by a black oval shape that appears to be a design element. There is a trademark symbol to the right of the word.
Surgical Instrument Service & Sterilization
Cover Letter for 510(k) Premarket Notification-MediSISS Reprocessed Non-Electric Biopsy Forceps
INDICATIONS FOR USE
. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. דער אין א 104265 510(k) Number (if known):
Device Name: MediSISS Reprocessed Non-electric GI Biopsy Forceps
Indications for Use:
The MediSISS Reprocessed Non-electric Biopsy Forceps are intended to be used to remove polyps, and obtain a specimen of tissue for microscopic examination.
PLEASE DO NOT WRITE BELOW THIS LINE—CONTINUE OF 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)
(Division Sign-Off)
David A. Tognozzi
(Division Sign-Off)
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number
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510(k) K042659: MediSISS Reprocessed Non-Electric ("Cold") GI Biopsy Forceps
The following models (and only the following models, with the descriptions below), which are the The following models (and only the tonowing models, with the associated in 1977)
subjects of this application, have been found substantially equivalent to the predicate devic listed in K042659.
| OEM Model | Description | Jaw O.D. | Length | Sheath Color |
|---|---|---|---|---|
| Bard 385 | Precisor* EXL Coated Biopsy Forceps, Alligator Cup | 2.3 mm | 230 cm | Blue |
| Microvasive 1537 | Radial Jaw 3 Biopsy Forcep with Needle | 2.2 mm | 240 cm | Orange |
| Microvasive 1597 | Radial Jaw, 3 Large Capacity Biopsy Forcep with Needle | 2.2 mm | 160 cm | Yellow |
| Microvasive 1599 | Radial Jaw 3, Large Capacity Biopsy Forcep with Needle | 2.2 mm | 240 cm | Orange |
| Olympus FB-240U | EndoJaw, Biopsy Forcep, Oval Cup, Fenestrated with Needle | 2.2 mm | 230 cm | Blue |
| Wilson-Cook SDE 2.5-230 | Shark Biopsy Forceps, Fenestrated without Spike (Red Handle) | 2.5 mm | 230 cm | Grey |