(90 days)
Not Found
No
The summary describes a physical protective sheath for surgical scopes and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is a protective sheath for surgical scopes, intended for transport, storage, and sterilization, not for treating a disease or condition.
No
The document states the device is a protective sheath for storage and sterilization of instruments, not for diagnosing medical conditions.
No
The device description clearly states it is a "polymer tube" and describes its physical characteristics and function as a protective sheath, indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "protection during the transport, storage and sterilization of certain ACMI scopes." This is a function related to the handling and processing of surgical instruments, not for performing diagnostic tests on samples taken from the human body.
- Device Description: The description of a "polymer tube in various widths and lengths with evenly distributed holes" designed to "snap onto ACMI telescopes for protection" aligns with a device for instrument handling and sterilization, not an IVD.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device's function is entirely focused on the physical protection and sterilization of surgical scopes, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Scope Guard protective sheath is intended for use during the transport, storage and sterilization of certain ACMI scopes for protection of these delicate instruments. It is not intended to be used alone for terminal sterilization but can be used in conjunction with an approved sterilization wrap to maintain sterility until the device is required for use. The ACMI scopes with Scope Guard can be wrapped, or placed into an approved sterilization tray for sterilization processing.
Product codes
OCU, KCT
Device Description
The Scope Guard Protective Sheath is a polymer tube in various widths and lengths with evenly distributed holes along the length of the shaft. It is designed to snap onto ACMI telescopes for protection during storage and sterilization.
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
ACMI Scope Guards have been bench tested for durability, sterile efficacy and material compatibility with several sterilization methods.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/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 top half of the circle. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
ACMI Corporation Ms. Christine Nichols, RAC 136 Turnpike Road Southborough, MA 01772-2104
JUL 2 7 2015
Re: K030684 Trade/Device Name: Scope Guard™ Protective Sheath Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCU, KCT Dated (Date on orig SE ltr): March 4, 2003 Received (Date on orig SE Itr): March 5, 2003
Dear Ms. Nichols,
This letter corrects our substantially equivalent letter of June 3, 2003.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
1
Page 2 -
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
V. Statement of Intended Use.
510(k) Number (if Known):
Device Name:
Scope Guard™ Protective Sheath
Indications For Use:
The Scope Guard protective sheath is intended for use during the transport, storage and sterilization of certain ACMI scopes for protection of these delicate instruments. It is not intended to be used alone for terminal sterilization but can be used in conjunction with an approved sterilization wrap to maintain sterility until the device is required for use. The ACMI scopes with Scope Guard can be wrapped, or placed into an approved sterilization tray for sterilization processing.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use (Optional Format 1-2-96)
David R. Lyman
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
Confidential and Proprietary to ACMI Corporation
3
Image /page/3/Picture/0 description: The image shows the logo for ACMI in black and white. The logo consists of three diagonal lines on the left, followed by the letters "ACMI" in a bold, sans-serif font. The diagonal lines are thicker at the top and taper towards the bottom, creating a sense of movement. The letters are evenly spaced and aligned with the diagonal lines, forming a cohesive and recognizable brand identity.
Scope Guard ™Protective Sheath 510(k) Premarket Notification
JUN - 3 2003
IV. Summary of Safety and Effectiveness
510(k) Summary for Scope Guard™ Protective Sheath
| A. Sponsor | ACMI CORPORATION
136 Turnpike Rd
Southborough, MA 01772 |
|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| B. Device Name | Scope Guard™ |
| C. Predicate Device | Polyvac Surgical Instrument Delivery System (K012105) |
| D. Device Description | The Scope Guard Protective Sheath is a polymer tube in
various widths and lengths with evenly distributed holes
along the length of the shaft. It is designed to snap onto
ACMI telescopes for protection during storage and
sterilization. |
| 1. Intended Use | The Scope Guard protective sheath is intended for use
during the transport, storage and sterilization of certain
ACMI scopes for protection of these delicate instruments. It
is not intended to be used alone for terminal sterilization but
can be used in conjunction with an approved sterilization
wrap to maintain sterility until the device is required for use.
The ACMI scopes with Scope Guard can be wrapped, or
placed into an approved sterilization tray for sterilization
processing. |
| 2. Technological Characteristics and Substantial Equivalence | The ACMI Scope Guard has been tested and compared to
similar devices. The Scope Guard is substantially equivalent
to the predicate described for the parameters tested. |
3. Performance Testing
ACMI Scope Guards have been bench tested for durability, sterile efficacy and material compatibility with several sterilization methods.