(104 days)
No
The device description and intended use focus on a mechanical balloon retraction system and do not mention any AI or ML components or functionalities.
No
The device is used to create a working cavity for endoscopic surgery by retracting organs and tissues; it does not treat or diagnose a disease or condition.
No.
The device is a surgical retraction system used to create a working cavity during endoscopic surgery by physically lifting organs and tissues, not to diagnose medical conditions.
No
The device description clearly lists multiple physical components (inflatable balloon, balloon sheath, tether, scrap, inflation bulb, attachment assembly, connector drape, tool holder) and describes a mechanical function (lifting and retracting organs). There is no mention of software.
Based on the provided text, the Airlift Jr.™ Balloon Retraction System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes the device's function in minimally invasive surgery for retracting organs and tissues to create a working cavity. This is a surgical tool used directly on the patient's body during a procedure.
- Device Description: The description details the physical components of the system (balloon, sheath, tether, etc.) and how it is used to mechanically lift and retract organs. This is a mechanical device for surgical manipulation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health. The Airlift Jr.™ is a surgical instrument used during surgery on the patient.
N/A
Intended Use / Indications for Use
The Airlift Jr.™ Balloon Retraction System has applications in minimally invasive surgery. It is indicated when endoscopic surgery is indicated and may be used as an alternative to insufflation for retracting organs and tissues thus creating a working cavity for endoscopic surgery. The Airlift Jr.™ Balloon Retraction System is used in conjunction with the Laparoliff™ previously cleared under premarket notification K921103 September 9, 1993. The Airlift Jr.™ Balloon Retraction System is not intended for use except as indicated. In addition, it is not intended for use when endoscopic surgery is contraindicated.
Product codes
Not Found
Device Description
The Airlift Jr.™ Balloon Retraction System is a single-use device which consist of an inflatable balloon, balloon sheath, tether and scrap, inflation bulb, and an attachment assembly which includes a connector drape and tool holder. The Airlift Jr.™ Balloon Retraction System is provided sterile and is developed to be used in conjunction with an Origin Laparolift Retraction System. This device is used to lift and retract organs and tissues to provide a space for endoscopic surgery without the use of gas insufflation.
The retraction of organs and tissues is achieved by first making a small incision then inserting the Airlift Balloon device. The Airlift Balloon is then attached to the Laparolift (mechanical distention arm) by means of the attachment assembly (tool holder and connector drape). The Laparolift is used to lift the Airlift Balloon device, and therefore the organs and tissues are raised to the height typically achieved by gas insufflation thus creating a working cavity for surgery. This function is equivalent to those described for the predicate device: Airlift™ Balloon Retraction System K942678, same as (Lifting Distention Balloon System, the predicate device will be refered to hence forth as Airlift™ Balloon Retraction System). The new device: Airlift™ Jr. has a balloon size of 4.1 inches deployed. The predicate device: Airlift™ Balloon Retraction System has a balloon size of 5.4 inches deployed. (See comparable chart on page 16-17). The connector drape, tool holder and Laparolift (mechanical distention) arm are the same as those cleared in the K921103, 1/15/93.
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)
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
SEP | | 1996
Class II
K962104
510(k) SUMMARY OF SAFETY & EFFECTIVENES
This 510(k) Summary details sufficient information to provide an understanding of the basis for a determination of substantial equivalence. For convenience, the summary is formatted pursuant to 21 CFR §807.92. This section may be used, as presented, to provide a substantial equivalence summary to anyone requesting it from the Agency.
21 CFR 8807.92 a(1)
| Submitter: | ORIGIN® Medsystems, Inc.
135 Constitution Avenue
Menlo Park, CA 94025
(415) 617-5142
contact person: Anthony Durso
date prepared: May 24, 1996 |
------------ | --------------------------------------------------------------------------------------------------------------------------------------------------------------- |
---|
21 CFR §807.92 a(2)
Trade name: | Airlift Jr.™ Balloon Retraction System |
---|---|
------------- | ---------------------------------------- |
Common name: | Retraction Instrument |
---|---|
Classification name: | Retraction Instrument |
21 CFR $807.92 a(3)
Identification of predicate(s): Substantial equivalence for the Airlift Jr. ™ Balloon Retraction System is based on its similarities to predicate device : the ORIGIN Airlift™ Balloon Retraction System. The Airlift Jr.™ Balloon Retraction System, shares the identical material, and technological characteristics as the predicate device. The Airlift Jr.™ Balloon Retraction System is also similar in intended use.
21 CFR §807.92 a(4)
Device Description-parts and function/concept: The Airlift Jr.™ Balloon Retraction System is a single-use device which consist of an inflatable balloon, balloon sheath, tether and scrap, inflation bulb, and an attachment assembly which includes a connector drape and tool holder. The Airlift Jr.™ Balloon Retraction System is provided sterile and is developed to be used in conjunction with an Origin Laparolift Retraction System. This device is used to lift and retract organs and tissues to provide a space for endoscopic surgery without the use of gas insufflation.
1
Class II
21 CFR §807.92 a(4)
Device Description-parts and function/concept: continued
The retraction of organs and tissues is achieved by first making a small incision then inserting the Airlift Balloon device. The Airlift Balloon is then attached to the Laparolift (mechanical distention arm) by means of the attachment assembly (tool holder and connector drape). The Laparolift is used to lift the Airlift Balloon device, and therefore the organs and tissues are raised to the height typically achieved by gas insufflation thus creating a working cavity for surgery. This function is equivalent to those described for the predicate device: Airlift™ Balloon Retraction System K942678, same as (Lifting Distention Balloon System, the predicate device will be refered to hence forth as Airlift™ Balloon Retraction System). The new device: Airlift™ Jr. has a balloon size of 4.1 inches deployed. The predicate device: Airlift™ Balloon Retraction System has a balloon size of 5.4 inches deployed. (See comparable chart on page 16-17).
2
Device Description-materials/physical properties: a table of the patient contact components, with their respective materials, is provided below. The connector drape, tool holder and Laparolift (mechanical distention) arm are the same as those cleared in the K921103, 1/15/93.
| Component
Name | Patient
Contact | Material | Predicate |
|-----------------------|--------------------|------------------------------|---------------------------------------------------|
| Inflation Balloon | yes | polyurethane
coated nylon | Airlift™ Balloon
Retraction System,
K942678 |
| Containment
Sheath | yes | polyurethane | Airlift™ Balloon
Retraction System,
K942678 |
| Tether and Strap | yes | polyurethane
coated nylon | Airlift™ Balloon
Retraction System,
K942678 |
| Tube Inflation | yes | polyurethane | Airlift™ Balloon
Retraction System,
K942678 |
The listed parts are currently being used in existing ORIGIN products, and therefore have been cleared for biocompatibility (safety) and effectiveness.
21 CFR §807.92 a(5)
Intended use and relationship to predicate(s): The Airlift Jr.™ Balloon Retraction System has applications in minimally invasive surgery. It is indicated when endoscopic surgery is indicated and may be used as an alternative to insufflation for retracting organs and tissues thus creating a working cavity for endoscopic surgery. The Airlift Jr.™ Balloon Retraction System is used in conjunction with the Laparoliff™ previously cleared under premarket notification K921103 September 9, 1993. The predicate device (Airlift™ Balloon Retraction System) has applications in laparoscopic surgery and is indicated and may be used as an alternative to insufflation for retracting organs and creating a working cavity for laparoscopic surgery. The predicate device is also used in conjunction with the Laparoliff™ .
3
Class II
The Airlift Jr.™ Balloon Retraction System is not intended for use except as indicated. In addition, it is not intended for use when endoscopic surgery is contraindicated.
CFR 8807.92 a(6)
Technological characteristics and relationship to predicate(s):
The Airlift Jr.™ Balloon Retraction System is substantially equivalent to the Airlift™ Balloon Retraction System previously cleared product. The Airlift Jr.™ Balloon Retraction System shares the identical function, technological characteristics and materials as the predicate device.
21 CFR §807.92 b
This submission's determination of substantial equivalence is based on similarities to the predicate devices in terms of intended uses, materials, and technological characteristics.
21 CFR §807.92 c
In accordance with the specifications of this subsection, this summary (4 pages) is its own section, and has been clearly identified as such.